NCT00059202

Trial of High-dose Urso in Primary Sclerosing Cholangitis

Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Sclerosing Cholangitis

Interventions

Type	Name	Description
DRUG	Ursodeoxycholic Acid	Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses
DRUG	Placebo	Placebo for Urso

Timeline

• Start date: 2002-07-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2003-04-22
• Last updated: 2021-05-03
• Results posted: 2021-04-08

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study