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

Conditions:Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Age Range:21 - 75
Start Date:February 13, 2018
End Date:August 31, 2020
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Phone:please email:

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A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986263 in Adults With Advanced Hepatic Fibrosis After Virologic Cure of Hepatitis C

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).

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

- 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

- 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

Other protocol defined inclusion/exclusion criteria could apply
We found this trial at
San Antonio, Texas 78215
Phone: 210-253-3426
San Antonio, TX
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