Facebook Icon Print Created with Sketch. Twitter Icon Created with Sketch. Created with Sketch. LinkedIn Icon Green Check Icon Created with Sketch. YouTube Icon Right Arrow Icon Mobile Menu Icon Chevron Right Icon Phone Icon Health Study Area: AutoImmune Disease Health Study Area: Blood Cancer Health Study Area: Cardiovascular Disease Health Study Area: Fibrosis Health Study Area: Gastrointestinal Cancer Health Study Area: Genitourinary Health Study Area: Head and Neck Cancer Health Study Area: Lung Cancer Health Study Area: Melanoma Health Study Area: Women's Cancer For Caregivers For Clinicians Communities FAQs For Parents For Patients Chevron Icon Bookmark Icon Map Icon Share Icon Direction Arrow Icon Direction Arrow Icon Page Icon Location Icon Search Icon External Link Icon Help Icon Error Icon Glossary Email Icon Gender Both Gender Male Gender Female Created with Sketch. Created with Sketch.

Please Log In/Join Now first, and then use this function!


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

Updated: 12 August, 2019   |   ClinicalTrials.gov

Print Friendly Summary

Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's 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


  • Gender(s)

  • 21-75

    Age Range

  • 1


  • Recruiting

Treatment Options

Study Arms
Experimental: Part 1 BMS-986263 45mg weekly
Drug: BMS-986263
Experimental: Part 1 BMS-986263 90mg weekly
Drug: BMS-986263
Placebo Comparator: Part 1 Placebo weekly
Other: Placebo
Experimental: Part 2 BMS-986263 45mg every 2 weeks
Drug: BMS-986263
Experimental: Part 2 BMS-986263 90mg every 2 weeks
Drug: BMS-986263
Experimental: Part 2 BMS-986263 90mg every 4 weeks
Drug: BMS-986263
Placebo Comparator: Part 2 Placebo every 2 weeks
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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Email Us

Have questions?
Email Us