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

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

This study has been completed.

Study NCT00200343. Last updated on September 12, 2005. Information provided by Mitsubishi Tanabe Pharma Corporation

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

serum alanine aminotransferase levels at 24-week of treatment

Secondary Outcome Measure ^†

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

Condition ^†

Chronic Hepatitis C

Intervention ^†

Drug: Ursodeoxycholic acid

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

600

Start Date ^†

July 2002

Completion Date

December 2004

Eligibility Criteria ^†

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 ^††

Location Countries ^†

Japan

Administrative Information Fields

NCT ID ^†

NCT00200343

Organization ID

MT711-01

Secondary IDs ^††

Study Sponsor ^†

Mitsubishi Tanabe Pharma Corporation

Collaborators ^††

Investigators ^†

Study Chair:

Masao Omata, MD

Department of Gastroenterology, University of Tokyo

Information Provided By

Mitsubishi Tanabe Pharma Corporation

Verification Date

September 2005

First Received Date ^†

September 12, 2005

Last Updated Date

September 12, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.