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	Phase
Chronic Hepatitis C	Drug: Ursodeoxycholic acid 150mg / day Drug: Ursodeoxycholic acid 600mg / day Drug: Ursodeoxycholic acid 900mg / day	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 A Hepatitis C

Drug Information available for: Hepatitis A Vaccines Ursodeoxycholic acid

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:

Alanine Aminotransferase at Baseline [ Time Frame: 0 week ] [ Designated as safety issue: No ]
Percentage Change of Alanine Aminotransferase From Baseline at Week 24 [ Time Frame: 24 weeks (from baseline to Week 24) ] [ Designated as safety issue: No ]
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100

Secondary Outcome Measures:

Aspartate Aminotransferase at Baseline [ Time Frame: 0 week ] [ Designated as safety issue: No ]
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24 [ Time Frame: 24 weeks (from baseline to Week 24) ] [ Designated as safety issue: No ]
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Gamma-glutamyl Transpeptidase at Baseline [ Time Frame: 0 week ] [ Designated as safety issue: No ]
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24 [ Time Frame: 24 weeks (from baseline to Week 24) ] [ Designated as safety issue: No ]
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100

Enrollment:	596
Study Start Date:	July 2002
Estimated Study Completion Date:	December 2004

Arms	Assigned Interventions
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

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

ClinicalTrials.gov Identifier:	NCT00200343 History of Changes
Other Study ID Numbers:	MT711-01
Study First Received:	September 12, 2005
Results First Received:	August 17, 2011
Last Updated:	September 29, 2011
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:

Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases

Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ursodeoxycholic Acid
Cholagogues and Choleretics
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012