Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
Megadott ok: 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 és Winter Park, Egyesült ÁllamokSee the 29 sites
- Phase
- 2. fázis
Where in Egyesült Államok
- BaltimoreBaltimore, Egyesült ÁllamokNo longer taking part
- Research Foundation of SUNY - University of BuffaloBuffalo, Egyesült ÁllamokNo longer taking part
- ChandlerChandler, Egyesült ÁllamokNo longer taking part
- Arizona Clinical Trials - TucsonChandler, Egyesült ÁllamokNo longer taking part
- The Institute for Liver Health-The Institute for Liver HealthChandler, Egyesült ÁllamokNo longer taking part
- University Diabetes & Endocrine ConsultantsChattanooga, Egyesült ÁllamokNo longer taking part
- DallasDallas, Egyesült ÁllamokNo longer taking part
- Fall RiverFall River, Egyesült ÁllamokNo longer taking part
- HoustonHouston, Egyesült ÁllamokNo longer taking part
- Iowa CityIowa City, Egyesült ÁllamokNo longer taking part
- Kansas CityKansas City, Egyesült ÁllamokNo longer taking part
- La JollaLa Jolla, Egyesült ÁllamokNo longer taking part
- Florida Research InstituteLakewood Rch, Egyesült ÁllamokNo longer taking part
- LancasterLancaster, Egyesült ÁllamokNo longer taking part
- LeesburgLeesburg, Egyesült ÁllamokNo longer taking part
- GastroIntestinal BioSciencesLos Angeles, Egyesült ÁllamokNo longer taking part
- McAllenMcAllen, Egyesült ÁllamokNo longer taking part
- MiamiMiami, Egyesült ÁllamokNo longer taking part
- Morehead CityMorehead City, Egyesült ÁllamokNo longer taking part
- New YorkNew York, Egyesült ÁllamokNo longer taking part
- NYU Langone Health-Department of MedicineNew York, Egyesült ÁllamokNo longer taking part
- OmahaOmaha, Egyesült ÁllamokNo longer taking part
- PhiladelphiaPhiladelphia, Egyesült ÁllamokNo longer taking part
- PhiladelphiaPhiladelphia, Egyesült ÁllamokNo longer taking part
- PhoenixPhoenix, Egyesült ÁllamokNo longer taking part
- Redwood CityRedwood City, Egyesült ÁllamokNo longer taking part
- RichmondRichmond, Egyesült ÁllamokNo longer taking part
- San AntonioSan Antonio, Egyesült ÁllamokNo longer taking part
- Winter ParkWinter Park, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT04267393
- Record updated
- 2024. szeptember 4.
- 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.