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

March 7, 2012 updated by: Mitsubishi Tanabe Pharma Corporation

A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. The primary endpoint was percent changes of serum alanine aminotransferase(ALT) levels at 24-week of administration compared to pre-administration levels and secondary endpoints, serum aspartate aminotransferase(AST) and gamma-glutamyltranspeptidase(gamma-GTP) levels. Further, changes of bile acid composition and HCV-RNA levels at 24-week of administration were examined.

Study Type

Interventional

Enrollment (Actual)

596

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • hongo, bunkyo-ku, Tokyo, Japan
        • Department of Gastroenterology, University of Tokyo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject must have a clinical diagnosis to apply the conservative medication for chronic hepatitis C.
  2. Serum alanine aminotransferase levels measured at 4-week before the initiation of treatment must be over 61 IU/mL.
  3. Subject's age must be 20 years or older.

Exclusion Criteria:

  1. Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period
  2. Subject who received a treatment of corticosteroids, immunosuppressive drugs, glycyrrhizic acid, cholestyramine or other drugs which could interfere with hepatic function during 8-week observation period.
  3. Subject with decompensated cirrhosis
  4. Subject infecting with other hepatic virus
  5. Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer
  6. Subject who require hospitalization for complications of the heart, kidney or pancreas
  7. Pregnancy
  8. Alcoholics
  9. Alcohol intake more than 27 ml/day
  10. Subject who involved in other clinical trial within 4 weeks before the start of observation period
  11. Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ursodeoxycholic acid 150mg / day
Drug: Ursodeoxycholic acid 150mg / day
Ursodeoxycholic acid, 150mg/ day, three times a day at meals
Experimental: Ursodeoxycholic acid 600mg / day
Drug: Ursodeoxycholic acid 600mg / day
Ursodeoxycholic acid, 600mg/ day, three times a day at meals
Experimental: Ursodeoxycholic acid 900mg / day
Drug: Ursodeoxycholic acid 900mg / day
Ursodeoxycholic acid, 900mg/ day, three times a day at meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alanine Aminotransferase at Baseline
Time Frame: 0 week
0 week
Percentage Change of Alanine Aminotransferase From Baseline at Week 24
Time Frame: 24 weeks (from baseline to Week 24)
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
24 weeks (from baseline to Week 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aspartate Aminotransferase at Baseline
Time Frame: 0 week
0 week
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
Time Frame: 24 weeks (from baseline to Week 24)
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
24 weeks (from baseline to Week 24)
Gamma-glutamyl Transpeptidase at Baseline
Time Frame: 0 week
0 week
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
Time Frame: 24 weeks (from baseline to Week 24)
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
24 weeks (from baseline to Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Investigators

  • Study Chair: Masao Omata, MD, Department of Gastroenterology, University of Tokyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2002

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

March 12, 2012

Last Update Submitted That Met QC Criteria

March 7, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT711-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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