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NCT02177136 · ClinicalTrials.gov registry record · Phase 2
Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)
A Phase 2 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 77
- Enrollment target
NCT02177136: Completed Phase 2 study, sponsored by Intercept Pharmaceuticals.
NCT02177136 is a Phase 2 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 77 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02177136, a Phase 2 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 77 participants
- Enrollment target
Study Summary
This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE) phase was conducted to evaluate the safety, tolerability, and efficacy of long-term, open-label use of OCA in participants with PSC who had completed the DB phase of the study.
Primary Outcome
The primary efficacy analysis compared the Week 24 change from Baseline in ALP between OCA treatment group and placebo using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and randomization strata, and Baseline as a covariate. Results are reported in U/L.
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2015-02-09 |
| Est. Completion | 2018-03-22 |
| Phase | Phase 2 |
What the finished NCT02177136 record still lists
NCT02177136 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02177136 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02177136 about?
NCT02177136 is a clinical study titled "Obeticholic Acid (OCA) in Primary Sclerosing Cholangitis (PSC)". This was a phase 2, double-blind (DB), placebo-controlled trial in participants with primary sclerosing cholangitis to evaluate the effect of obeticholic acid on liver biochemistry, in particular, serum alkaline phosphatase; and, safety. The long-term safety extension (LTSE) phase was conducted to e...
What is the current status of trial NCT02177136?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 77 participants. The study started on 2015-02-09. Estimated completion is 2018-03-22.
What interventions are being tested in trial NCT02177136?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT02177136?
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 NCT02177136's enrollment target sits among peer trials
77 891st of 2000 higher than 1,108 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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