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A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03420768•Bristol-Myers Squibb

View on ClinicalTrials.gov

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

Age

21 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
•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

Locations (1)

The Texas Liver Institute

San Antonio, Texas, United States

Key Dates

Start Date

February 14, 2018

Primary Completion Date

December 10, 2018

Completion Date

May 28, 2019

Last Updated

February 4, 2022

Enrollment

ACTUAL participants

Conditions

Hepatic CirrhosisLiver Fibrosis

Interventions

BMS-986263

DRUG

Placebo

OTHER

Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis

NCT04429100

Liver Fibrosis

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RECRUITINGPHASE3

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

NCT06632444

Metabolic Dysfunction Associated Steatohepatitis (MASH)Liver Fibrosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Rapid Breath-hold Quantitative Macromolecular Proton Fraction Imaging for Liver Fibrosis

LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis

Evaluation of Non-Invasive Tests for Metabolic Liver Disease

Biomarkers in the Diagnosis and Prognosis of NAFLD

Endosonographic Shear Wave Elastography to Assess Liver and Splenic Fibrosis

Development of Non-Invasive MRI Applications for Liver Fibrosis and Inflammation