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NCT00570765 · ClinicalTrials.gov registry record · Phase 2
Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
A Phase 2 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00570765: Completed Phase 2 study, sponsored by Intercept Pharmaceuticals.
NCT00570765 is a Phase 2 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00570765, a Phase 2 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
Primary Outcome
The percent change in serum ALP from baseline to Day 85 is reported. The baseline value used was the mean of the pretreatment Screening and Day 0 evaluations.
Interventions
- DRUG Placebo
- DRUG Obeticholic Acid (OCA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-01-17 |
| Est. Completion | 2017-09-25 |
| Phase | Phase 2 |
What the finished NCT00570765 record still lists
NCT00570765 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00570765 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00570765 about?
NCT00570765 is a clinical study titled "Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)". The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.
What is the current status of trial NCT00570765?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2008-01-17. Estimated completion is 2017-09-25.
What interventions are being tested in trial NCT00570765?
The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).
Who is sponsoring clinical trial NCT00570765?
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 NCT00570765's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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