drugset / Trial / NCT00608894
LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2007-12
- Primary completion
- 2009-04
- Completion
- 2009-07
Outcome
Outcome not reported
Stopped (Enrollment): “Study was discontinued due to slow enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 50 mg | — |
| Comparator | Azathioprine | Small molecule | 100 mg | — |
| Subject | Tacrolimus | Small molecule | 1 mg | — |
| Subject | Tacrolimus | Small molecule | 2 mg | — |