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NCT02548351 · ClinicalTrials.gov registry record · Phase 3
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
A Phase 3 study, sponsored by Intercept Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 2,477
- Enrollment target
NCT02548351: Clinical Trial Phase 3 study, sponsored by Intercept Pharmaceuticals.
NCT02548351 is a Phase 3 study that was terminated before completion, run by Intercept Pharmaceuticals. The registered enrollment target is 2,477 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (221% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02548351, a Phase 3 study, was terminated before completion, sponsored by Intercept Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 2,477 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
Primary Outcome
All potential liver-related clinical outcomes that occurred after administration of first dose of investigational product were reviewed and adjudicated by blinded, independent Hepatic Outcomes Committee(HOC). Adjudicated results were used to assess effect of OCA, compared to placebo in conjunction with established local standard of care, on clinical outcomes in participants with NASH as measured by time to first occurrence of any of following adjudicated events, derived as a composite event endp
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,477 participants |
| Start Date | 2015-09-22 |
| Est. Completion | 2023-09-15 |
| Phase | Phase 3 |
Why NCT02548351 stopped before completion
NCT02548351 is an interventional study that assigns participants to a tested intervention. Its 2,477 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (221% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02548351 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02548351 about?
NCT02548351 is a clinical study titled "Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment". The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.
What is the current status of trial NCT02548351?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 2,477 participants. The study started on 2015-09-22. Estimated completion is 2023-09-15.
What interventions are being tested in trial NCT02548351?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (DRUG).
Who is sponsoring clinical trial NCT02548351?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02548351's enrollment target sits among peer trials
2,477 88th of 2000 higher than 1,913 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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