A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
Status: | Recruiting |
---|---|
Conditions: | Gastrointestinal, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 21 - 75 |
Updated: | 1/25/2019 |
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, |
Email: | Clinical.Trials@bms.com |
Phone: | please email: |
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).
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
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
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