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NCT01473524 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
A Phase 3 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 217
- Enrollment target
NCT01473524: Completed Phase 3 study, sponsored by Intercept Pharmaceuticals.
NCT01473524 is a Phase 3 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 217 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01473524, a Phase 3 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 217 participants
- Enrollment target
Study Summary
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).
Primary Outcome
Percentage of participants at Month 12 with ALP \< 1.67 x upper limit of normal (ULN) and total bilirubin ≤ ULN and ALP decrease of ≥ 15% from baseline.
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2012-01 |
| Est. Completion | 2018-12-17 |
| Phase | Phase 3 |
What the finished NCT01473524 record still lists
NCT01473524 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01473524 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01473524 about?
NCT01473524 is a clinical study titled "Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis". The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on safety in participants with primary biliary cirrhosis (PBC).
What is the current status of trial NCT01473524?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 217 participants. The study started on 2012-01. Estimated completion is 2018-12-17.
What interventions are being tested in trial NCT01473524?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT01473524?
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 NCT01473524's enrollment target sits among peer trials
217 1332nd of 2000 higher than 669 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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