drugset / Trial / NCT00550862
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2007-10
- Primary completion
- 2009-08
- Completion
- 2010-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obeticholic Acid | Small molecule | 10 mg | Oral |
| Subject | Obeticholic Acid | Small molecule | 25 mg | Oral |
| Subject | Obeticholic Acid | Small molecule | 50 mg | Oral |
| Background | Ursodeoxycholic Acid | Small molecule | — | — |