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Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C

NCT00200343 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2026-01-07

Study results available
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Summary

This study is a 24-week multicenter, randomized, double-blind control trial with ursodeoxycholic acid (UDCA) in patients with chronic hepatitis C in Japan. The primary objectives of this study are to verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.

Conditions

  • Chronic Hepatitis C

Interventions

DRUG

Ursodeoxycholic acid 150mg / day

Ursodeoxycholic acid, 150mg/ day, three times a day at meals

DRUG

Ursodeoxycholic acid 600mg / day

Ursodeoxycholic acid, 600mg/ day, three times a day at meals

DRUG

Ursodeoxycholic acid 900mg / day

Ursodeoxycholic acid, 900mg/ day, three times a day at meals

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Masao Omata, MD · Department of Gastroenterology, University of Tokyo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-07-31
Completion
2004-12-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00200343 on ClinicalTrials.gov