Conditions: Liver Cirrhosis, Biliary
Keywords: PBC, Primary Biliary Cirrhosis, Liver,
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 165
Healthy volunteers: no

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

Arms:
arm 1: INT-747 10 mg once daily in combination with URSO for 12 weeks. arm 2: INT-747 25 mg once daily in combination with URSO for 12 weeks. arm 3: INT-747 50 mg once daily in combination with URSO for 12 weeks. arm 4: Placebo once daily in combination with URSO for 12 weeks.

Interventions: intervention 1: INT-747 intervention 2: Ursodeoxycholic Acid (URSO) intervention 3: Placebo
Intervention descriptions: intervention 1: Once a day (QD) by mouth (PO) intervention 2: Stable dose for at least 6 months prior to screening. Dose as prescribed by physician. intervention 3: Placebo

Protocol document: