Clinical Trial: Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study of INT 747 (6α-ethyl Chenodeoxycholic Acid (6-ECDCA)) in Combination With Ursodeoxycholic Acid (URSO®, UDCA) in Patients With Primary Biliary Cirrhosis

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 Summary: None provided
Sponsor: Intercept Pharmaceuticals

Current Primary Outcome: Alkaline Phosphatase (ALP). [ Time Frame: Baseline and 12 weeks ]

The primary efficacy endpoint was the relative (%) change in plasma ALP from pretreatment values. The prestudy consensus opinion of the investigators was that a placebo-substracted ALP fall of ≥ 10% would be clinically significant.


Original Primary Outcome: In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on both 1) alkaline phosphatase (AP) levels and 2) safety [ Time Frame: 12 weeks ]

Current Secondary Outcome:

  • Serum Gamma-Glutamyl Transpeptidase (GGT) [ Time Frame: Baseline and 12 weeks ]
    Percent change in serum gamma-glutamyl transpeptidase (GGT) from baseline to Day 85/early termination.
  • Alanine Aminotransferase (ALT) [ Time Frame: Baseline and 12 weeks ]
    Mean percent change in serum alanine aminotransferase (ALT) from baseline to Day 85/early termination.
  • Plasma Trough Concentrations of INT-747 and Its Major, Known Metabolites [ Time Frame: 12 Weeks ]


Original Secondary Outcome: In patients with primary biliary cirrhosis (PBC) taking UDCA, to assess the effects of INT-747 on 1) hepatocellular injury and liver function, 2) disease-specific and general health symptoms and 3) biomarkers of hepatic inflammation and fibrosis. [ Time Frame: 12 weeks ]

Information By: Intercept Pharmaceuticals

Dates:
Date Received: October 27, 2007
Date Started: October 2007
Date Completion:
Last Updated: February 10, 2012
Last Verified: February 2012