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NCT00550862 · ClinicalTrials.gov registry record · Phase 2
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
A Phase 2 study, sponsored by Intercept Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
NCT00550862: Clinical Trial Phase 2 study, sponsored by Intercept Pharmaceuticals.
NCT00550862 is a Phase 2 study that was terminated before completion, run by Intercept Pharmaceuticals. The registered enrollment target is 165 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00550862, a Phase 2 study, was terminated before completion, sponsored by Intercept Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
Study Summary
The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
Primary Outcome
Blood samples were collected for the analysis of serum ALP. Baseline was defined as the last observed value before the first dose of investigational product (Day 0). Percent change from Baseline was calculated as Post Baseline minus Baseline value divided by Baseline value and multiplied by 100.
Interventions
- DRUG Placebo
- DRUG INT-747
- DRUG Ursodeoxycholic Acid (URSO)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2007-10 |
| Est. Completion | 2010-12 |
| Phase | Phase 2 |
Why NCT00550862 stopped before completion
NCT00550862 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00550862 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00550862 about?
NCT00550862 is a clinical study titled "Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)". The primary hypothesis is that INT-747 will cause a reduction in alkaline phosphatase levels in Primary Biliary Cirrhosis patients, over a 12 week treatment period, as compared to placebo.
What is the current status of trial NCT00550862?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2007-10. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00550862?
The interventions under investigation include: Placebo (DRUG), INT-747 (DRUG), Ursodeoxycholic Acid (URSO) (DRUG).
Who is sponsoring clinical trial NCT00550862?
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 NCT00550862's enrollment target sits among peer trials
165 410th of 2000 higher than 1,588 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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