Terminated
PHASE2
INTERVENTIONAL
NCT00550862
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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
Interventions
Name:
INT-747
Type:
DRUG
Description:
Once a day (QD) by mouth (PO)
Name:
Ursodeoxycholic Acid (URSO)
Type:
DRUG
Description:
Stable dose for at least 6 months prior to screening. Dose as prescribed by physician.
Name:
Placebo
Type:
DRUG
Description:
Placebo
Primary Outcomes
Measure:
Double-blind Phase: Percent Change From Baseline in Serum Alkaline Phosphatase (ALP)
TimeFrame:
Baseline and Up to Day 85
Description:
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.
Trial Information
NCT ID
NCT00550862
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Intercept Pharmaceuticals
Last Updated
December 15, 2025