Trial of High-dose Urso in Primary Sclerosing Cholangitis

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Placebo tablet that is identical (size, color, etc) to experimental ursodeoxycholic acid tablet.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo for Urso

Ursodeoxycholic acid

Ursodeoxycholic acid 28-30 mg/kg/day

Group Type EXPERIMENTAL

Ursodeoxycholic Acid

Intervention Type DRUG

Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses

Interventions

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Ursodeoxycholic Acid

Ursodeoxycholic Acid 28-30 mg/kg/day in divided doses

Intervention Type DRUG

Placebo

Placebo for Urso

Intervention Type DRUG

Other Intervention Names

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UDCA

Eligibility Criteria

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Inclusion Criteria

* Chronic cholestatic disease of at least six months' duration.
* Serum alkaline phosphatase at least 1 ½ times the upper limits of normal.
* Retrograde, operative, percutaneous, or magnetic resonance cholangiography demonstrating intrahepatic and/or extrahepatic biliary duct obstruction, beading, or narrowing consistent with PSC within one year of the study entry.
* Liver biopsy in the previous one year which is available for review and compatible with the diagnosis of PSC. Compatible biopsy features include fibrous cholangitis, ductopenia with periportal inflammation and biliary fibrosis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No