Trials / Terminated
TerminatedNCT00550862
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
A Study of INT 747 (6α-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 165 (actual)
- Sponsor
- Intercept Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
None provided
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | INT-747 | Once a day (QD) by mouth (PO) |
| DRUG | Ursodeoxycholic Acid (URSO) | Stable dose for at least 6 months prior to screening. Dose as prescribed by physician. |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2007-10-01
- Primary completion
- 2009-08-01
- Completion
- 2010-12-01
- First posted
- 2007-10-30
- Last updated
- 2024-02-06
- Results posted
- 2012-01-23
Locations
32 sites across 8 countries: United States, Austria, Canada, France, Germany, Netherlands, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00550862. Inclusion in this directory is not an endorsement.