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Recruiting

A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C - IM025-006

Updated: 09 April, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 21-75

    Age Range

  • 1

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: BMS-986263
Drug: BMS-986263
Placebo Comparator: Placebo
Other: Placebo

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Participants must provide documentation showing a sustained virologic response (SVR) for at least 1 year (52 weeks) prior to the date of screening (SVR is defined as a negative hepatitis C RNA greater than or equal to 12 weeks from the end of therapy) - Participants must have METAVIR Stage 3 or 4 (or equivalent if using other classification; eg, Ishak) Exclusion Criteria: - Other causes of liver disease (eg, alcoholic liver disease, HBV [serologically positive as determined using United States Centers for Disease Control and Prevention guidance for interpretation of hepatitis B serologic test results], autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, iron overload, alpha-1-antitrypsin deficiency, NASH, hemochromatosis) - Participants having liver diseases associated with infection with any other hepatitis virus - Detectable HCV RNA at screening - Child-Pugh score > 6 - Model for End-Stage Liver Disease score >12 - Evidence of HCC at screening based on alpha-fetoprotein (AFP) levels: AFP > 100 ng/mL (> 82.6 IU/mL) OR AFP ≥ 50 and ≤ 100 ng/mL (≥ 41.3 IU/mL and ≤ 82.6 IU/ mL) with liver ultrasound showing findings suspicious for HCC, or any imaging technique (eg, magnetic resonance imaging [MRI] or computed tomography; based on local assessment), or ultrasound - Blood transfusion in the last 6 months prior to screening due to the risk of re-infection with HCV, HBV, HIV, etc - Participant has any disease or condition which, in the opinion of the investigator, might compromise patient safety (eg, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, skeletal, central nervous system, or compliment-mediated disease); or other conditions that may interfere with the absorption, distribution, metabolism, or excretion of BMS 986263, or would place the participant at increased risk Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us