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NCT00608894 · ClinicalTrials.gov registry record · Phase 2
LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis
A Phase 2 study, sponsored by Veloxis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT00608894: Clinical Trial Phase 2 study, sponsored by Veloxis Pharmaceuticals.
NCT00608894 is a Phase 2 study that was terminated before completion, run by Veloxis Pharmaceuticals. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00608894, a Phase 2 study, was terminated before completion, sponsored by Veloxis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).
Primary Outcome
Percent of patients that achieve biochemical remission of (AIH) at Month 6 during treatment with LCP-Tacro + prednisone or azathioprine + prednisone. Biochemical remission is defined as ALT, total bilirubin and gamma globulin within normal limits.
Interventions
- DRUG Azathioprine
- DRUG LCP-Tacro (tacrolimus)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2007-12 |
| Est. Completion | 2009-07 |
| Phase | Phase 2 |
Why NCT00608894 stopped before completion
NCT00608894 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Azathioprine is the first listed.
NCT00608894 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00608894 about?
NCT00608894 is a clinical study titled "LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis". An open-label, multi-center, prospective, randomized study to evaluate the efficacy, safety and tolerability of LCP-Tacro tablets given once daily vs. azathioprine, each in combination with prednisone, for the treatment of autoimmune hepatitis (AIH).
What is the current status of trial NCT00608894?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2007-12. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00608894?
The interventions under investigation include: Azathioprine (DRUG), LCP-Tacro (tacrolimus) (DRUG).
Who is sponsoring clinical trial NCT00608894?
This trial is sponsored by Veloxis Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00608894's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 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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