Efficacy and Safety of BMS-986263 in Adults with Compensated Cirrhosis from NASH

JRCT ID: jRCT2011200024

Registered date:01/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Compensated cirrhosis from NASH
• Date of first enrollment: 17/03/2021
• Target sample size: 270
• Countries of recruitment: USA (including Puerto Rico),Japan,Canada,Japan,Brazil,Japan,Germany,Japan,Switzerland,Japan,France,Japan,Spain,Japan,Korea,Japan,Taiwan,Japan,Belgium,Japan,United Kingdom,Japan,Italy,Japan,Israel,Japan,Argentina,Japan
• Study type: Interventional

Intervention(s)

Arm A: BMS-986263 low dose QW
Arm B: BMS-986263 high dose QW
Arm C: Placebo QW

Outcome(s)

• Primary Outcome: Improvement in liver fibrosis as determined by liver biopsy
• Secondary Outcome: Safety, tolerability, PK of BMS-986263

Key inclusion & exclusion criteria

• Age minimum: >= 21age old
• Age maximum: <= 75age old
• Gender: Both
• Include criteria: -Participants with liver biopsy fibrosis score stage 4 performed within 6 months

Exclude criteria

-Hepatic decompensation
-Known immunocompromised status or any disease or condition which might compromise participant safety

Related Information

• Primary Sponsor: Oliveira De Claudia
• Secondary ID(s): NCT04267393