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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 12, 2005

Start Date ^ICMJE

July 2002

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

serum alanine aminotransferase levels at 24-week of treatment

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

serum aspartate aminotransferase and gamma-glutamyltranspeptidase) levels at 24-week of treatment

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A 24-Week Multicenter Double-Blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C

Brief Summary

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 Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Hepatitis C

Intervention ^ICMJE

Drug: Ursodeoxycholic acid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

600

Completion Date

December 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

Subject who received a treatment of antiviral agents (interferon) within 20 weeks before the start of 8-week observation period
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.
Subject with decompensated cirrhosis
Subject infecting with other hepatic virus
Subject receiving a treatment for autoimmune disease, alcohol or drug-induced hepatic disorder, neoplasia, hepato-cholangiolar disease, fulminant hepatitis or peptic ulcer
Subject who require hospitalization for complications of the heart, kidney or pancreas
Pregnancy
Alcoholics
Alcohol intake more than 27 ml/day
Subject who involved in other clinical trial within 4 weeks before the start of observation period
Subject with a history of sensitivity to ursodeoxycholic acid or bile acid-products

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00200343

Responsible Party

Study ID Numbers ^ICMJE

MT711-01

Study Sponsor ^ICMJE

Mitsubishi Tanabe Pharma Corporation

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Masao Omata, MD

Department of Gastroenterology, University of Tokyo

Information Provided By

Mitsubishi Tanabe Pharma Corporation

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP