ALERT CONTENT PLACEHOLDER

Research Studies

Research Study: AIH GSK222291, Starlight

Study Purpose:

A Dose-Finding, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy and Safety of GSK4532990 for Steatohepatitis in Adults with Alcohol-related Liver Disease (ALD)

Inclusion Criteria:

  • Cirrhotic – compensated and decompensated
  • Alcohol consumption within 4 months

Exclusion Criteria:

N/A

Contact Person:

Jenny and Danie
Phone: 647 466 7861

Research Study: Assure CB 8025-31731-RE

Study Purpose:

An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Seladelpar in Subjects with Primary Biliary Cholangitis (PBC)

Inclusion Criteria:

  • Participated in a PBC study with seladelpar that allow rollover into CB8025-31731-RE
​

Exclusion Criteria:

  • Treatment-related AE leading to study drug discontinuation in a previous PBC study with seladelpar.
  • ​AST/ALT> 3xULN

Contact Person:

Ambreen
Phone: 647 466 7816

Nilofur
Phone: 647 466 7685

Research Study: BELief

Study Purpose:

A phase 2 clinical study that will test the effects of Belimumab in an open label trial recruiting patients with autoimmune hepatitis.

Inclusion Criteria:

Two Groups:

  • In adult patients with confirmed AIH and ongoing disease activity at the time of inclusion, despite a history of corticosteroids and/or second line therapies
  • In adult patients with confirmed AIH and for whom disease is in drug-induced remission at the time of inclusion
​

Exclusion Criteria: undefined

Contact Person:

Madeline
Phone: 647 984 8146

Research Study: CaNAL

Study Purpose:

Longitudinal observational cohort study of patients diagnosed with PBC, AIH or PBC & AIH overlap.

Inclusion Criteria:

  • PBC / AIH Dx or overlap
​

Exclusion Criteria: undefined

Contact Person:

Madeline
Phone: 647 984 8146

Claire
Phone: 226 929 8126

Research Study: Canal Registry

Study Purpose:

PBC/AIH Registry

Inclusion Criteria:

  • All patients diagnosed with PBC, AIH or OS

Exclusion Criteria:

n/a

Contact Person:

Madeline
Phone: 647 984 8145

Research Study: ELFIDENCE CLIN-60190-454, Ipsen Bioscience Inc.

Study Purpose:

A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants with Primary Biliary Cholangitis (PBC)​

Inclusion Criteria:

  • Cirrhotic
  • Not on fibrates or OCA

Exclusion Criteria:

N/A

Contact Person:

Ambreen and Jenna
Phone: 647 466 7562

Research Study: Factors Associated with rPSC Post Liver tx.

Study Purpose:

International Retrospective Cohort of patients with PSC post Liver transplant, aiming to find the factors that affect reoccurrence of P​SC.

Inclusion Criteria:

  • Age over 18
  • Have a pre-transplant diagnosis of PSC
​

Exclusion Criteria:

  • Any chronic liver disease that is not PSC. Additional cause for liver disease.
​

Contact Person:

Shani
Phone: 416 624 3153

Research Study: Glisten PBC

Study Purpose:

A two-part, randomized, placebo controlled, double blind, multicenter, Phase 3 study to evaluate the efficacy and safety of linerixibat for the treatment of cholestatic pruritus in participants with primary biliary cholangitis (PBC).

Inclusion Criteria:

  • PSC
  • Serum alkaline phosphatase concentration >1.5 times the upper limit of normal (ULN)
  • Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) concentration ≤5 × ULN
  • Serum total bilirubin ≤1.5 × ULN, in the absence of Gilbert's syndrome or hemolysis
​

Exclusion Criteria:

  • Total bilirubin > 2.0 ULN
  • ALT > 6 x ULN
​

Contact Person:

Ambreen
Phone: 647 466 7816

Research Study: Global PBC

Study Purpose:

International PBC registry

Inclusion Criteria:

  • All patients with PBC
​

Exclusion Criteria:

N/A

Contact Person:

Shani
Phone: 416 624 3153

Research Study: Immunotolerance in PBC

Study Purpose:

Autoantigen peptides delivered to the lymphatic system of patients with specific human leukocyte antigen (HLA) profiles (using small delivery tools called NanoDisks) could shift patient immunological profiles from autoimmunity to immunotolerance. This will be explored through a two stage prospective, pilot feasibility study.

Inclusion Criteria:

  • Pre-transplant, male or female, 18+ with an established diagnosis of PBC
  • Without a diagnosis of a clinically relevant competing liver injury (as determined by the standard of care evaluation)
​

Exclusion Criteria:

  • Liver transplant recipients
  • Clinically diagnosed with a dominant alternative cause of liver disease, in the opinion of the investigator
​

Contact Person:

Aisha
Phone: 647 382 2792

Research Study: KOWA K-808-2.01

Study Purpose:

A Phase 2, randomized, Placebo-controlled, Parallel Group, Multicenter 12-week study with a 52-week extension to evaluate the efficacy and safety of two doses of K-808 (Pemafibrate) in subjects with Primary Biliary Cholangitis with inadequate Response to Ursodeoxycholic Acid and/or Obeticholic Acid treatment.​

Inclusion Criteria:

  • PBC with LP > 1.5 ULN

Exclusion Criteria: undefined

Contact Person:

Ambreen
Phone: 647 466 7816

Research Study: LLSAT PBC (Long-term Glisten)

Study Purpose:

Long-term Safety and Tolerability Study of Linerixibat for the Treatment of Cholestatic Pruritus in Participants with Primary Biliary Cholangitis

Inclusion Criteria:

  • Participants with a diagnosis of PBC and a history of associated pruritus.
  • Participants must have completed the main treatment period(s) in a prior eligible linerixibat clinical study (BAT117213, GLIMMER or GLISTEN).
​

Exclusion Criteria:

N/A

Contact Person:

Ambreen
Phone: 647 466 7816

Research Study: Mirum VLX-301

Study Purpose:

A randomized double-blind Placebo-Controlled study to evaluate the efficacy and safety of Voloxibat in the treatment of Cholestatic Pruritus in patient with Primary Sclerosing Cholangitis (VISTAS).​

Inclusion Criteria:

  • Moderate to severe itch

    Exclusion Criteria:

    Undefined​

    Contact Person:

    Jenna
    Phone: 647 466 7562​

    Research Study: Pacific PBC/PSC

    Study Purpose:

    Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of EP547 in Subjects with Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis

    Inclusion Criteria:

    • Participants who have proven PBC and PSC
    • Itch score > 4
    ​

    Exclusion Criteria:

    N/A

    Contact Person:

    Ambreen
    Phone: 647 466 7816

    Research Study: PSC-WIND

    Study Purpose:

    A global multi-centre prospective observational cohort study.

    Inclusion Criteria:

    • PSC patient
    • No other liver dx
    ​

    Exclusion Criteria: undefined

    Contact Person:

    Madeline
    Phone: 647 984 8146

    Claire
    Phone: 226 929 8126

    Research Study: Q.Rare.Li

    Study Purpose:

    A multi-central interventional study of emotional support by peer-patients who live with PBC, PSC or AIH. TCLD is a sub-site.

    Inclusion Criteria:

    • For all parties: (1) PBC, PSC or AIH dx; (2) 18 years or older
    • For patients: (a) Subjectively need psychological support; (b) English speakers. Able to understand and provide informed consent
    ​

    Exclusion Criteria:

    • Life-threatening health status
    • Acute suicidality
    • Ongoing psychotherapy support
    • Severe cognitive, auditory or visual impairment
    • Unable to complete the assessment
    ​

    Contact Person:

    Shani
    Phone: 416 624 3153

    Research Study: Symptom Burden

    Study Purpose:

    Observational study: longitudinal, questionnaire-base study; investigating the impact of clinical and socioeconomic factors on symptoms.

    Inclusion Criteria:

    • PBC/PSC patient
    • Pre-transplant
    ​

    Exclusion Criteria: undefined

    Contact Person:

    Aisha
    Phone: 647 382 2792

    Research Study: Transform

    Study Purpose:

    A 52-week, Randomized, Placebo controlled, Double blind, Adaptive Phase 2b/3 Trial of Setanaxib with a 52 week Extension Phase in Patients with Primary Biliary Cholangitis (PBC) and Elevated Liver Stiffness

    Inclusion Criteria:

    • Definite or probable PBC diagnosis
    • Serum ALP ≥1.67×ULN
    • Liver stiffness of ≥8.8 kPa
    ​

    Exclusion Criteria:

    • Historical or current hepatic decompensation event
    • History of liver transplantation, current placement on a liver transplant list
    • Cirrhosis with complications
    • Total bilirubin >2×ULN
    • Plasma ALT >3×ULN and/or AST >3×ULN
    • INR >1.2
    • (eGFR) below 60
    • Thyroid-stimulating hormone >ULN at screening
    • Competing etiology for liver disease
    ​

    Contact Person:

    Nilofur
    Phone: 647 466 7685

    Research Study: Vistas PSC

    Study Purpose:

    A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis

    Inclusion Criteria:

    • Participants who have proven PSC
    • Itch score > 4
    ​

    Exclusion Criteria:

    • Decompensated cirrhosis
    • AST or ALT > 5 x ULN
    ​

    Contact Person:

    Ambreen
    Phone: 647 466 7816

    Research Study: B-Well

    Study Purpose:

    Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment with Bepirovirsen in Nucleos(t)ide Analogue-treated Participants with Chronic Hepatitis B Virus (B-Well 1)-REB approved for PA1

    Inclusion Criteria:

    • Plasma or serum HBsAg concentration >100 IU/mL but ≤ 3000 IU/ml.

    On stable NUC

    • HBV DNA <90 IU/mL
    • HBeAg-negative or positive

    Exclusion Criteria:

    • History of or suspected liver cirrhosis and/or evidence of cirrhosis
    • History of vasculitis or presence of symptoms and signs of potential vasculitis [e.g., vasculitic rash, skin ulceration, repeated blood detected in urine without identified cause] or history/presence of other diseases that may be associated with vasculitis condition (e.g., systemic lupus erythematosus, rheumatoid arthritis, relapsing polychondritis, mononeuritis multiplex)
    • History of alcohol or drug abuse/dependence

    Contact Person:

    Zhaolu
    Phone: 647 466 7648

    Research Study: MARCH Study

    Study Purpose:

    A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects with Chronic Hepatitis B Virus Infection

    Inclusion Criteria:

    1. 18-65 years old
    2. On continuous NRTI therapy for at least 2 months prior to screening
    3. HBV DNA < 100 IU/mL at screening
    4. HBsAg > the lower limit of detection
    5. Negative anti-HBs at screening
    ​

    Exclusion Criteria:

    ALT or aspartate aminotransferase (AST) > 3x ULN, TSH and free T4 above the ULN or below the LLN, platelets < 90,000 cells/mm3

    Contact Person:

    Jenny
    Phone:647 466 7861

    Research Study: Vision

    Study Purpose:

    Phase II Investigator-initiated study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection.

    Inclusion Criteria:

    On stable NUC

    • HBV DNA <90 IU/mL
    • HBsAg 500-10,000 IU/mL
    • ALT<45

    Exclusion Criteria:

    Undefined​

    Contact Person:

    Jenny
    Phone: 647 466 7861

    Research Study: A Comprehensive Multicenter Retrospective Study on Neoadjuvant Chemotherapy in Intrahepatic Cholangiocarcinoma Treatment - Neo-iCCA

    Study Purpose:

    This multicenter study aims to evaluate the effect of neoadjuvant chemotherapy on both short-term perioperative and long-term oncologic outcomes after surgical resection of iCCA compared to upfront resection. This will involve characterization of the epidemiology, histopathology, clinical features, treatment course and molecular abnormalities of these cohorts of patients. These outcomes will be compared in a propensity-score matched analysis.​

    Inclusion Criteria:

    All iCCA patients who underwent curative-intent resection at UHN will be considered for inclusion in this study. Additional patients from other participating institutions will be included; The inclusion period is Jan-2010 to Dec-2023. This will allow for at least 3 months of follow-up data. Data collection for each patient will range between 01/Jan/2010 and 31/Dec/2023.​

    Exclusion Criteria:

    N/A

    Contact Person:

    Shiva Babakhani
    Giselle Caballero
    Roxana Bucur

    Research Study: Amethyst and Sapphire Studies: Treatment patterns, risk factors for recurrence, and outcomes among patients with hepatocellular carcinoma treated with resection and/or ablation

    Study Purpose:

    This study aims to describe real-world data on patient demographic and clinical characteristics, treatment patterns, outcomes as well as factors associated with the risk of recurrence in patients diagnosed with hepatocellular carcinoma (HCC) in Canada, China, South Korea, and in France, Germany, Italy, Portugal, and the UK. All objectives will be analyzed for the overall patients included in the study; and all objectives (except for the third secondary objective and the exploratory objective) will further be analyzed by regions of strategic importance to AstraZeneca, ie.​ EUCAN (including the sites from France, Germany, Italy, Portugal, the UK and Canada), APAC (China and South Korea).

    Inclusion Criteria:

    Patients diagnosed with HCC who were initially treated with liver resection and/or tumour ablation during the study period (between 01 January 2017 and 30 June 2022)​

    Exclusion Criteria:

    N/A

    Contact Person:

    Shiva Babakhani
    Roxana Bucur

    Research Study: Atezolizumab and Bevacizumab Pre-Liver Transplantation for Patients with Hepatocellular Carcinoma Beyond Milan Criteria: A Feasibility Study - HMLTO002

    Study Purpose:

    Sponsor: Houston Methodist Research Institute
    Funding: Genentech, Inc. 

    Patients with hepatocellular carcinoma (HCC) beyond Milan Criteria (MC) who are undergoing evaluation for or waitlisted for liver transplantation will be treated with 6 months of neoadjuvant/downstaging atezolizumab plus bevacizumab while receiving standard of care transarterial chemoembolization (TACE) or transarterial radioembolization (TARE). We hypothesize that atezolizumab and bevacizumab can appropriately bridge patients with HCC beyond MC to transplantation and not increase the risk of 1-year post-transplant rejection.



    Inclusion Criteria:

    Histologically or radiologically proven HCC, without extrahepatic disease. Patients, who consent to a fresh tissue biopsy, and under the discretion of the Investigators, will provide a baseline biopsy sample for diagnosis and correlative studies. Archival tumour tissue may be used to confirm HCC in patients who do not consent to a fresh tissue biopsy; Must be considered, undergoing evaluation for or waitlisted for liver transplantation.​

    Exclusion Criteria:

    N/A

    Contact Person:

    Shiva Babakhani
    Roxana Bucur

    Research Study: BRCA 1/2 and PALB2 and non-core DNA damage repair-related alterations in biliary tract cancer: international study to assess clinical, therapeutic and molecular implications; Investigator initiated

    Study Purpose:

    ​This study will be a multicenter, observational research project conducted on an international scale to collect retrospective data on patients diagnosed with advanced BTC. Data collection will encompass clinical characteristics, molecular profiles, and treatment response outcomes. National and international centers with established expertise in BTC and cancer genetics will participate, ensuring a robust and diverse dataset.

    Inclusion Criteria:

    Eligible patients will be those who have undergone comprehensive molecular profiling through next-generation sequencing (NGS), specifically analyzing core and non-core HRD genes (as listed in table 1) under the HPB Oncology Research Group study - LeGresley Biliary Registry study (REB # 21-5237) from 26th November 2021 up until 11th December 2024. Data on Cholangiocarcinoma patients from this study who have consented to future research will be collected from the LeGresley Biliary Registry REDCap database. Data will be retrospectively collected for these patients until the patient is deceased or lost to follow up at UHN.​

    Exclusion Criteria:

    N/A

    Contact Person:

    Roxana Bucur​

    Research Study: Characterization of Genomic Abnormalities in BTC Tumours and Treatment Implications - BTC Genomics, Investigator Initiated

    Study Purpose:

    The study aims to develop a comprehensive catalogue of genomic abnormalities found in BTC tumours, with a goal of identifying potential new treatment options for patients based on their genomic and transcriptomic profiles.​

    Inclusion Criteria:

    BTC patients enrolled in the LeGresley Biliary Registry study (21-5237) and/or with signed Princess Margaret Cancer Biobank (PMCB) consent will be eligible for this study. We estimate that approximately 50 samples will be analyzed annually from prospective sample collection and another 100-200 samples will be analyzed from previously banked tissue (retrospective samples). Therefore, a total of 600-700 patients will be included in the analysis over 10 years; however, not every sub-analysis will include all samples. Samples will be accessed from PMCB or the clinical archives (LMP).

    Exclusion Criteria:

    N/A

    Contact Person:

    Erin Winter​

    Research Study: Cholangiocarcinoma at UHN – presentation and outcomes - CCA Insights; Investigator Initiated

    Study Purpose:

    In this study, which combines retrospective data analysis with prospective elements, we aim to identify patients diagnosed with CCA who are referred to or treated at UHN and evaluate their outcomes through data analysis. We aim to develop a detailed dataset to assess the patients' condition at diagnosis, risk factors, treatment options, and their success rates. Furthermore, we will examine treatment outcomes, including tumour presence, recurrence, and the development of new tumours for CCA patients. Our ultimate goal is to deepen understanding and pinpoint areas for future research to enhance patient care.​

    Inclusion Criteria:

    The database will accommodate patients with a diagnosis of CCA who are 18 years or older with a radiological or pathological diagnosis of Cholangiocarcinoma between January 1st 2000 onwards seen or treated at UHN.​​

    Exclusion Criteria:

    N/A

    Contact Person:

    Roxana Bucur​

    Research Study: Downstaging of Hepatocellular Carcinoma with Macrovascular Invasion by Radiotherapy and Atezolizumab plus Bevacizumab Followed by Liver Transplantation – A Prospective Trial, Investigator Initiated, Transplant Oncology Grant Competition

    Study Purpose:

    This is an open-label study to assess the safety of radiotherapy (SBRT or Y90-RE) with AtezoBev treatment in pre-transplant setting for HCC with MVI; The primary aim is to investigate the down staging efficacy of this multimodal treatment protocol for patients with advanced HCC with MVI within 20 patients who receive LT. The objective is to assess the number of patients enrolled, which achieve eligibility for liver transplant wait listing and subsequent LT. ​

    Inclusion Criteria:

    Patients with locally advanced HCC with MVI on imaging (Vp 1-3) (inclusion and exclusion criteria below), with no other contraindications for LT, can be considered for inclusion. Tumour biopsy is required to rule out poorly differentiated HCC (a contraindication for LT).​

    Exclusion Criteria:

    N/A

    Contact Person:

    Shiva Babakhani
    Giselle Caballero
    Roxana Bucur

    Research Study: Immunobiological profiling of biliary structures - Biliary Bioprofile; Investigator Initiated

    Study Purpose:

    In this translational study, we aim to develop a comprehensive sample collection (obtained during standard of care visits) that includes blood, bile, tissue, urine and stool from patients with biliary tree strictures and masses (benign or malignant lesions /tumours /inflammatory strictures of the biliary tree) with the ultimate goal of identifying potential new treatment options for patients with varying liver diseases based on their genomic profiles.

    Inclusion Criteria:

    Adult patients 18 and over seen at UHN that have a confirmed diagnosis of Primary Sclerosing Cholangitis based on current AASLD Guidelines, or those who have suspicious biliary tree pathology including but not limited to benign or malignant mass/ tumour/ structure of the biliary tree.

    Exclusion Criteria:

    N/A

    Contact Person:

    Roxana Bucur​

    Research Study: JZP598-302; (HERIZON-BTC-302)

    Study Purpose:

    An open-label randomized trial of the efficacy and safety of zanidatamab with standard-of-care therapy against standard-of-care therapy alone for advanced HER2-positive biliary tract cancer​

    Inclusion Criteria:

    Histologically or cytologically confirmed BTC (GBC, ICC or ECC). HER2-positive disease (defined as IHC 3+; or IHC 2+/ISH+) by IHC and ISH assay (in participants with IHC2+ tumors)​

    Exclusion Criteria:

    N/A​

    Contact Person:

    Nurse: Guillaume Cheung
    CDC: Harjot Chahal

    Research Study: Molecular Epidemiology of Hepatobiliary Tumors - HBT Study; Investigator Initiated

    Study Purpose:

    In this study, we aim to develop a comprehensive catalogue of genomic abnormalities found in HBT tumours, with a goal of identifying potential new treatment options for patients based on their genomic and transcriptomic profiles.​​

    Inclusion Criteria:

    Clinical or pathological diagnosis of HBTs. HBTs include Hepatocellular carcinoma (HCC) and, Biliary tumours (Cholangiocarcinoma - CCA and Gallbladder Cancer). All patients seen at UHN​

    Exclusion Criteria:

    N/A

    Contact Person:

    Nadia Rukavina
    Roxana Bucur

    Research Study: NEOLANGIO

    Study Purpose:

    Perioperative Therapy with Gemcitabine/Cisplatin/Nab-Paclitaxel and Rilvegostomig (AZD2936) for Patients with Resectable Intrahepatic Cholangiocarcinoma (iCCA) - A Phase II Trial (NEOLANGIO)​

    Inclusion Criteria:

    Histologically proven intrahepatic cholangiocarcinoma; Complete surgical resection of the tumor must be achievable (*Resectability is at the discretion of the investigators at each site but must be discussed at a multidisciplinary tumour board). Resection should include a portal lymphadenectomy as per standard of care.

    Exclusion Criteria:

    N/A

    Contact Person:

    Giselle Caballero
    Mary (Lan) Wei
    Guillaume Cheung

    Research Study: Patient-derived and murine models for the Research and Evaluation of Discovery and Innovation in Combination Therapies for Biliary tract Cancer; Investigator Initiated

    Study Purpose:

    PDOs and PDXs will be assessed for their response to corresponding GMSAT and/ or chemotherapy. Drug treatment will be administered to cultured cells in a range of concentrations to determine the dose-response curve, and models will be ranked according to their IC50/IC75 values. Similarly, PDX models will be treated with the corresponding inhibitors in vivo and classified according to response. To complement the depth of response evaluation, we will also track the duration of PDX response or growth control in cases where only disease stabilization is achieved.

    Inclusion Criteria:

    BTC patients enrolled in the LeGresley Biliary Registry study (21-5237) and/or with signed Princess Margaret Cancer Biobank (PMCB) consent will be eligible for this study. We estimate that approximately 50 samples will be analyzed annually from prospective sample collection and another 100-200 samples will be analyzed from previously banked tissue (retrospective samples).; We will also involve a cohort already established in Medical School Hannover, Germany. This site will contribute approximately 150 samples and data, enriching the study with a diverse patient population. This site has a repository of samples and prospective protocols for Biliary Tract Cancers. Samples and data for patients that meet the study eligibility criteria will be transferred to UHN.

    Exclusion Criteria:

    N/A

    Contact Person:

    Roxana Bucur​

    Research Study: Perioperative Therapy with Durvalumab Plus Tremelimumab for Patients with Resectable Hepatocellular Carcinoma - A Phase II Trial

    Study Purpose:

    This is a phase II (NEOTOMA), open-label multi-centre study to assess safety of Durvalumab and Tremelimumab treatment in pre-surgical setting for upfront resectable Hepatocellular Carcinoma (HCC), followed by adjuvant Durvalumab.​

    Inclusion Criteria:

    Histologically proven resectable HCC (early and intermediate stage HCC); Must consent to provide biopsy sample prior to treatment​​​

    Exclusion Criteria:

    N/A

    Contact Person:

    Shiva Babakhani
    Giselle Caballero
    Roxana Bucur

    Research Study: ProvIHDe (DIM-95031-002)

    Study Purpose:

    An open-label early access phase 3b study of ivosidenib in patients with a pretreated locally advanced or metastatic cholangiocarcinoma (CCA) ​

    Inclusion Criteria:

    Histologically confirmed CCA; Not eligible for curative resection, transplantation or ablation IDH1 mutation and at least 1 prior line of systemic treatment​​

    Exclusion Criteria:

    N/A

    Contact Person:

    Nurse: Ching (Serena) Kao
    CDC: Tenzin Yewang

    Research Study: The Legresley Biliary Registry; Investigator Initiated

    Study Purpose:

    The LeGresley Biliary Registry will aim to enroll all patients presenting to UHN with a biliary tract cancer diagnosis at any point in their treatment trajectory. Blood samples will be collected to assess their underlying genetic predisposition to BTC. Additional specimens will be collected in this study and include tissue for tumour genetic make-up and stool samples to explore bacterial composition in the gut. Patients will be asked to complete validated questionnaire(s) based on personal and family history and epidemiologic risk factors. This will help us identify new trends in risk factors and age at presentation of patients with BTC. It will also foster epidemiologic research to understand the recent rise in incidence of this deadly disease.​

    Inclusion Criteria:

    Clinical, radiological or pathological diagnosis of BTC (including mixed-histologies), all patients seen and/or treated at UHN​


    Exclusion Criteria:

    N/A

    Contact Person:

    Erin Winter​

    Research Study: The Prevalence of Predisposing Germline Variants in Biliary Tract Cancer, Investigator Initiated

    Study Purpose:

    We propose a single-center study to investigate the germline testing and clinical information of patients diagnosed with BTC. The study will report the retrospective clinic-based data from the University Health Network in Toronto, Canada. The study will include patients referred for germline genetic counselling with a diagnosis of BTC between April 1, 2021, and December 31, 2024. The study hopes to include up to 165 patients’ data.

    Inclusion Criteria:

    The study population will include patients aged ≥18 years with a pathologically confirmed diagnosis of BTC. Mixed hepatocellular carcinoma/cholangiocarcinoma will be allowed. Neuroendocrine tumours without adenocarcinoma component will be excluded.​

    Exclusion Criteria:

    N/A​​

    Contact Person:

    Erin Winter​

    Research Study: TYR430-101

    Study Purpose:

    A Multicenter, Open-label, First-in-Human Study of TYRA-430 in Advanced Hepatocellular Carcinoma and Other Solid Tumors with Activating FGF/FGFR pathway aberrations (SURF-431)​

    Inclusion Criteria:

    Histologically confirmed locally advanced unresectable/metastatic HCC or histologically confirmed advanced solid tumor with documented FGF/FGFR pathway alterations​

    Exclusion Criteria:

    N/A

    Contact Person:

    Stephen Lam
    Sharadha Kolappan

    Research Study: UHN-MHH Hepatocellular Carcinoma Collaborative Database Study - Combined HCC Outcomes; Investigator initiated

    Study Purpose:

    Combined retrospective and prospective multicenter cohort study, including patients who undergo systemic and locoregional therapies for HCC to assess the clinical outcomes and overall survival in two large expert centers from two different countries. Analysis of the combined collected data will provide insights into key clinical outcomes, such as the effectiveness of various treatment modalities on patient survival and disease progression. By evaluating factors such as liver function, tumour characteristics, and response to therapies, the study will help identify predictors of treatment success, improve patient management strategies, and guide future research into optimizing care for HCC patients.​

    Inclusion Criteria:

    Patients with a pathological or radiological diagnosis of HCC who have received/receiving locoregional or systemic therapy; Patients who have previously consented to be part of the HCC database (CAPCR# 17-5892)​

    Exclusion Criteria:

    N/A

    Contact Person:

    Roxana Bucur​

    Research Study: Atea Pharmaceuticals, C-Beyond

    Study Purpose:

    Phase 3, randomized, controlled, open-label study to compare the efficacy and safety of Bemnifosbuvir-Ruzasvir fixed-dose combination (BEM.RZR FDC) versus Sofosbuvir-Velpatasvir fixed-dose combination (SOF.VEL FDC) in subjects with chronic Hepatitis C Virus (HCV) infection​

    Inclusion Criteria:

    • HCVRNA > 1,000
    • Non-cirrhotic or compensated cirrhotic

    Exclusion Criteria:

    N/A

    Contact Person:

    Danie
    Phone: 647 466 7861

    Research Study: Inspire

    Study Purpose:

    To determine if screening for HCV using rapid diagnostics during an acute psychiatric admission with inpatient initiation of HCV treatment is superior to standard post-discharge referral and treatment.

    Inclusion Criteria:

    • HCV infection (positive RNA test)
    • Aged 18 to 80
    • Willingness and capacity to provide informed consent
    ​

    Exclusion Criteria:

    • Presence or history of decompensated cirrhosis (evidence of decompensation with history of either ascites, variceal hemorrhage, or hepatic encephalopathy)
    • Platelets < 75,000/mm3, total albumin < 35 g/L, total bilirubin >34 μmol/L, INR >1.5
    • History of current or past hepatocellular carcinoma
    • Prior HCV antiviral therapy with DAA with or without peginterferon/ribavirin (with the exception of HCV re-infection)
    • Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease
    • Pregnancy/breast-feeding/inability to use contraception
    • Use of concomitant contraindicated medications
    • Not eligible for privately funded or publicly funded (Ontario Drug Benefit/federal plan) drug coverage for HCV in Ontario
    ​

    Contact Person:

    Bethany
    Phone: 647 466 7524

    Research Study: Pharm-C

    Study Purpose:

    The hypothesis being tested is that linkage to care and treatment will be more effective in a community pharmacy than through referral to a tertiary care hospital for management of HCV among people on stable OAT, or other populations who experience barriers to care but use community pharmacy services.

    Inclusion Criteria:

    • HCV infection
    • HCV RNA > 1,000 IU/mL
    • Aged 18 to 80
    • Willingness and capacity to provide informed consent
    ​

    Exclusion Criteria:

    • Presence of or history of decompensated cirrhosis. This will be defined as evidence of clinical decompensation (history of either ascites, variceal hemorrhage, or hepatic encephalopathy/confusion), and Child-Pugh-Turcotte and MELD score will also be used to assess this using laboratory investigations and clinical findings.
    • Platelets < 75,000/mm3, total albumin < 35 g/L, total bilirubin (total and direct) > 34.2 μmol/L, INR >1.5
    • History of current or past hepatocellular carcinoma
    • HBV (HBsAg +ve) co-infection or untreated HIV co-infection
    • Prior HCV antiviral therapy with direct-acting antivirals with or without peginterferon/ribavirin
    • Chronic liver disease other than mild non-alcoholic or alcoholic fatty liver disease from a cause other than HCV
    • Significant co-morbid illness that precludes inclusion in the opinion of the investigator
    • Life expectancy of less than 1 year. If clarity is required, the provider who delivered the diagnosis will be contacted.
    • Pregnancy/breast-feeding/inability to use contraception
    • Use of concomitant contraindicated drugs
    ​

    Contact Person:

    Bethany
    Phone: 647 466 7524

    Research Study: Bluejay Therapeutics, Azure

    Study Purpose:

    A global, randomized, open-label, multicenter, phase 2b/3 trial evaluating BJT-778 vs delayed treatment for the treatment of chronic hepatitis Delta Infection (AZURE-1)​

    Inclusion Criteria:

    • HDV
    • ALT> ULN
    • Non-cirrhotic CTP < 6
    • On NUC or willing to take NUC

    Exclusion Criteria:

    N/A

    Contact Person:

    Zhaolu
    Phone: 647 466 7648

    Research Study: Ultragenyx

    Study Purpose:

    UX701 is an investigational gene therapy that is being developed for the treatment of Wilson disease. The purpose of this study is to evaluate the safety and efficacy of 3 dose levels of UX701, select a safe and efficacious dose, and evaluate the safety and efficacy of the selected dose in patients with Wilson disease. This first-in-human study is intended to be an adequate, well-controlled study that will provide evidence of safety and efficacy to support marketing applications.

    Inclusion Criteria:

    Eligible individuals must meet all of the following criteria:

    1. Individuals ≥ 18 years of age at the time of informed consent.
    2. Confirmed diagnosis of Wilson disease based on genetic confirmation of heterozygous or homozygous biallelic ATP7B mutation.
    3. Stable Wilson disease as evidenced by ongoing copper chelator (ie, penicillamine, trientine) and/or zinc therapy for at least 6 months at Screening, with no medication or dose changes for at least 6 months at Screening.
    4. Ongoing restriction of high copper containing foods for at least 6 months at Screening and continued through study participation.
    5. Willing and able to comply with all study procedures and requirements, including frequent blood collection, total urine collection over a 24-hour period, PRO assessments, and long-term follow-up.
    6. From the time of informed consent through 52 weeks following IP administration on Day 0 (Stage 1) or 104 weeks following IP administration on Day 0 (Stage 2), female subjects of childbearing potential and fertile male subjects must consent to use highly effective contraception as defined by the US FDA and Clinical Trial Facilitation and Coordination Group Recommendations Related to Contraception and Pregnancy Testing in Clinical Trials (Version 1.1 dated 21 Sep 2020) (CTFG, 2020) to prevent pregnancy and potential transmission of the AAV vector. Refer to Appendix 2. If female, agree not to become pregnant. If male, agree not to father a child or donate sperm.
    7. Provide informed consent after the study has been explained and before any study-related procedures are performed.
    ​

    Exclusion Criteria:

    Individuals who meet any of the following exclusion criteria are not eligible to participate:

    1. Detectable pre-existing antibodies to the AAV9 capsid (AAV9 DetectCDx).
    2. Stage 1 only: History of copper chelator or zinc therapy noncompliance, in the Investigator's judgment, within 6 months prior to Screening.
    3. History of liver transplant.
    4. Decompensated hepatic cirrhosis or presence of advanced liver disease as evidenced by portal hypertension, ascites, splenomegaly, esophageal varices, or hepatic encephalopathy.
    5. Significant hepatic inflammation as evidenced by any of the following laboratory abnormalities:
      • ALT or AST > 3.0 × ULN
      • Total bilirubin > 2.0 × ULN
      • Alkaline phosphatase > 2.5 × ULN
    6. Model for End-Stage Liver Disease (MELD) score > 13.
    7. Hemoglobin < 9 g/dL.
    8. Presence of Stage 3 or higher chronic kidney disease based on estimated glomerular filtration rate < 60 mL/min/1.73 m2.
    9. Marked neurological deficit or compromise that, in the Investigator's opinion, would interfere with the subject's safety or ability to participate in the study.
    10. Moderate to severe depression, recent or active suicidal ideation with intent or suicidal behavior, psychosis, or unstable psychiatric illness meeting any of the following criteria:
      • Moderate to severe depression defined as a Beck Depression Inventory-II (BDI-II) score > 20 at Screening
      • History of suicide attempt (including actual, interrupted, or aborted attempt) within 5 years prior to Screening, or history of suicidal ideation with intent within 6 months prior to Screening − Patients with a history of suicide attempt more than 5 years prior to Screening should be evaluated by a mental health care professional before enrolling in the study
      • Columbia Suicide Severity Rating Scale (C-SSRS) assessment with a Yes response to Question 4 (past 6 months only) or Question 5 (past 6 months only) at Screening • Moderate to severe psychosis at Screening, defined as a total Brief Psychiatric Rating Scale (BPRS) score > 10 for the following questions: Question 3 (Emotional Withdrawal), Question 11 (Suspiciousness), Question 12 (Hallucinatory Behavior), Question 15 (Unusual Thought Content), and Question 16 (Blunted Affect) (Park et al., 2015)
      • History of psychiatric inpatient hospitalization within 1 year prior to Screening or psychiatric medication changes within 8 weeks prior to Screening 11. History of active or latent tuberculosis, history of positive purified protein derivative (PPD) or tine test, positive QuantiFERON-TB Gold tuberculosis test, or positive T-SPOT.TB test if QuantiFERON-TB Gold tuberculosis test is not available.
    11. History of active or latent tuberculosis, history of positive purified protein derivative (PPD) or tine test, positive QuantiFERON-TB Gold tuberculosis test, or positive T-SPOT.TB test if QuantiFERON-TB Gold tuberculosis test is not available.
    12. Presence of active hepatitis B virus infection as defined by the laboratory assessment criteria listed in Table 13.
    13. Presence of active hepatitis C virus infection as defined by the laboratory assessment criteria listed in Table 14.
    14. History of human immunodeficiency virus infection.
    15. Presence or history of any condition that, in the Investigator's opinion, would interfere with participation, pose undue risk, or confound interpretation of study results. This includes any intercurrent febrile or nonfebrile illness during Screening, including common viral infections, influenza, and COVID-19 until full clinical recovery.
    16. Pregnant or breastfeeding or planning to become pregnant (self or partner):
      • Stage 1: At any time during the 52 weeks following IP administration on Day 0
      • Stage 2: At any time during the 104 weeks following IP administration on Day 0
    17. Female subject of childbearing potential who has a positive serum pregnancy test at Screening or a positive urine pregnancy test at Baseline, or who is unwilling to have additional pregnancy tests during the study. Female subjects are considered not of childbearing potential if they have not experienced menarche, are postmenopausal (defined as having no menses for at least 12 months without an alternative medical cause), or are permanently sterile due to total hysterectomy, bilateral salpingectomy, or bilateral oophorectomy.
    18. Known hypersensitivity to UX701 or its excipients, copper chelators (ie, penicillamine, trientine), zinc or oral corticosteroids that, in the Investigator's judgment, places the subject at increased risk for adverse effects.
    19. Participation in another gene transfer study or use of another gene transfer product before or during study participation.
    20. Use of any investigational therapy within 30 days prior to Screening (or other duration at the discretion of the Investigator in consultation with the Ultragenyx Medical Director) or during study participation.
    21. History of illicit drug use within 60 days prior to Screening or positive results from a urine drug screen during the Screening Period, not including medications prescribed for a diagnosed medical condition or use of cannabinoids for recreational or medicinal purposes.
    22. Subjects with known hypersensitivity to amide-containing local anesthetics are excluded from participating in the optional liver biopsy substudy.
    ​

    Contact Person:

    Bethany
    Phone: 416 034 04800 ext. 6569

    Research Study: 218672HORIZON

    Study Purpose:

    A Phase 2b Study to Evaluate the Efficacy and Safety of GSK4532990 in Adults with NASH (HORIZON)

    Inclusion Criteria:

    • The liver biopsy must show a NAS ≥4 with at least 1 point each
    ​

    Exclusion Criteria:

    • Cirrhosis
    ​

    Contact Person:

    Nilofur
    Phone: 647 466 7685

    Research Study: BIO89-100-131

    Study Purpose:

    Phase 3 study to evaluate the efficacy and safety of Pegozafermin in subjects with metabolic dysfunction-associated Steatohepatitis (MASH) and Fibrosis.​

    Inclusion Criteria:

    Biopsy confirmed MASH F2 and F3​

    Exclusion Criteria:

    ​U​ndefined

    Contact Person:

    Nishat
    Phone: 647 466 7954

    Research Study: Madrigal-19

    Study Purpose:

    A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients with Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH OUTCOMES)

    Inclusion Criteria:

    • Fibrosis F4
    • 3 of 4 Metabolic factors
    • No Biopsy
    • NAS 4 or more
    • BMI >30 kg/m2
    ​

    Exclusion Criteria:

    • Platelets <70,000
    ​

    Contact Person:

    Nilofur
    Phone: 647 466 7685

    Research Study: MK6024-17

    Study Purpose:

    A phase 2a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Efinopegdutide (MK-6024) in adults with compensated Cirrhosis secondary to metabolic dysfunction-associated Steatohepatitis.

    Inclusion Criteria:

    Has a diagnosis of compensated cirrhosis secondary to MASH indicative of Stage 4 on a liver biopsy obtained ≤2 years before screening.

    OR

    Has a liver stiffness ≥14 kPa based on CVTE (FibroScan®).

    No GLP-1 within the last 6 months.

    Exclusion Criteria: undefined

    Contact Person:

    Nilofur
    Phone: 647 466 7685

    Research Study: OnX Liver Assessment, Oncoustics Inc.

    Study Purpose:

    To assess the performance of the OnX exam on patients with suspected or confirmed liver disease with the goal of comparing the OnX output stiffness estimates to FibroScan® liver stiffness measurements​.

    Inclusion Criteria:

    Patients (age 22-80) with confirmed or suspected hepatocellular chronic liver disease (CLD),​ including NAFLD, Chronic HVB and/or HCV.

    Exclusion Criteria:

    N/A

    Contact Person:

    Jenna
    Phone: 647 466 7562
    Quicklinks
    Back to Top