Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
Reason given: Trial terminated because of lack of efficacy in the short term acute phase.
Key facts
- Where
- Baltimore, Buffalo, Chandler, Chattanooga, Dallas, Fall River, Houston, Iowa City, Kansas City, La Jolla, Lakewood Rch, Lancaster, Leesburg, Los Angeles, McAllen, Miami, Morehead City, New York, Omaha, Philadelphia, Phoenix, Redwood City, Richmond, San Antonio, and Winter Park, United StatesSee the 29 sites
- Phase
- Phase 2
Where in United States
- BaltimoreBaltimore, United StatesNo longer taking part
- Research Foundation of SUNY - University of BuffaloBuffalo, United StatesNo longer taking part
- ChandlerChandler, United StatesNo longer taking part
- Arizona Clinical Trials - TucsonChandler, United StatesNo longer taking part
- The Institute for Liver Health-The Institute for Liver HealthChandler, United StatesNo longer taking part
- University Diabetes & Endocrine ConsultantsChattanooga, United StatesNo longer taking part
- DallasDallas, United StatesNo longer taking part
- Fall RiverFall River, United StatesNo longer taking part
- HoustonHouston, United StatesNo longer taking part
- Iowa CityIowa City, United StatesNo longer taking part
- Kansas CityKansas City, United StatesNo longer taking part
- La JollaLa Jolla, United StatesNo longer taking part
- Florida Research InstituteLakewood Rch, United StatesNo longer taking part
- LancasterLancaster, United StatesNo longer taking part
- LeesburgLeesburg, United StatesNo longer taking part
- GastroIntestinal BioSciencesLos Angeles, United StatesNo longer taking part
- McAllenMcAllen, United StatesNo longer taking part
- MiamiMiami, United StatesNo longer taking part
- Morehead CityMorehead City, United StatesNo longer taking part
- New YorkNew York, United StatesNo longer taking part
- NYU Langone Health-Department of MedicineNew York, United StatesNo longer taking part
- OmahaOmaha, United StatesNo longer taking part
- PhiladelphiaPhiladelphia, United StatesNo longer taking part
- PhiladelphiaPhiladelphia, United StatesNo longer taking part
- PhoenixPhoenix, United StatesNo longer taking part
- Redwood CityRedwood City, United StatesNo longer taking part
- RichmondRichmond, United StatesNo longer taking part
- San AntonioSan Antonio, United StatesNo longer taking part
- Winter ParkWinter Park, United StatesNo longer taking part
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT04267393
- Record updated
- 4 September 2024
- Original description
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).Read full original descriptionShow less
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).
Inclusion: Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months; Men and women must agree to follow methods of contraception.
Exclusion: Prior exposure to BMS-986263; Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator; Known immunocompromised status or any disease or condition which might compromise participant safety; Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests; Hepatic decompensation; Other protocol-defined inclusion/exclusion criteria apply.