A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
Condition: Hepatic Cirrhosis; Liver Fibrosis
MeSH terms: Hepatitis C; Liver Cirrhosis; Fibrosis
Intervention: BMS-986263; Placebo
Intervention description: Administered by intravenous (IV) infusion; Administered by intravenous (IV) infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 21 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a study of experimental medication BMS-986263 in adult patients with advanced hepatic
      fibrosis (scar tissue in the liver caused by inflammation that is far on in progress) after
      the patient is cured of hepatitis C (an infection caused by a virus that attacks the liver
      and leads to inflammation).
    

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