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NCT04267393 · ClinicalTrials.gov registry record · Phase 2
Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Terminated
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
NCT04267393: Clinical Trial Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT04267393 is a Phase 2 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04267393, a Phase 2 study, was terminated before completion, sponsored by Bristol-Myers Squibb.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
Study Summary
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).
Primary Outcome
Percentage of participants who achieve ≥ 1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score), as determined by liver biopsy after 12 weeks of treatment. For the NASH CRN Fibrosis Score, fibrosis is staged on a 0 to 4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). Responder is defined as achieved \>=1 stage improvement in liver fibrosis (NASH CRN Fibrosis Score) as determined by liv
Interventions
- OTHER Placebo
- DRUG BMS-986263
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2024-02-09 |
| Phase | Phase 2 |
Why NCT04267393 stopped before completion
NCT04267393 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04267393 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04267393 about?
NCT04267393 is a clinical study titled "Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) 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).
What is the current status of trial NCT04267393?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2021-03-17. Estimated completion is 2024-02-09.
What interventions are being tested in trial NCT04267393?
The interventions under investigation include: Placebo (OTHER), BMS-986263 (DRUG).
Who is sponsoring clinical trial NCT04267393?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04267393's enrollment target sits among peer trials
124 564th of 2000 higher than 1,437 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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