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

Sponsor:	Mitsubishi Tanabe Pharma Corporation
Information provided by:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT00200343

Purpose

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.

Condition	Intervention
Chronic Hepatitis C	Drug: Ursodeoxycholic acid

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A 24-Week Multicenter Double-Blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ursodeoxycholic acid

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

serum alanine aminotransferase levels at 24-week of treatment

Secondary Outcome Measures:

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

Estimated Enrollment:	600
Study Start Date:	July 2002
Estimated Study Completion Date:	December 2004

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200343

Locations

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

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

Study Chair:

Masao Omata, MD

Department of Gastroenterology, University of Tokyo

More Information

No publications provided

Study ID Numbers:	MT711-01
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00200343 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:

Chronic hepatitis C, Ursodeoxycholic acid

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Hepatitis, Chronic
Flaviviridae Infections
Gastrointestinal Agents
Hepatitis, Viral, Human
Pharmacologic Actions
Ursodeoxycholic Acid

Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Cholagogues and Choleretics
Hepatitis C
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 27, 2009