Conditions: Primary Sclerosing Cholangitis
Keywords: Urso PSC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 150
Healthy volunteers: no

Brief summary:
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will be approximately five years with important clinical endpoints such as death, eligibility for liver transplantation, changes in histology and cholangiogram as well as liver biochemistries and quality of life data collected.

Detailed description:

Arms:
arm 1: Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet. arm 2: Ursodeoxycholic acid 28-30 mg/kg/day

Interventions: intervention 1: Ursodeoxycholic Acid intervention 2: Placebo
Intervention descriptions: intervention 1: Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses intervention 2: Placebo for Urso

Protocol document: