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

This study has been completed.

Sponsored by: 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

MedlinePlus related topics:   Hepatitis    Hepatitis C   

ChemIDplus related topics:   Ursodeoxycholic acid   

U.S. FDA Resources

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

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:

  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
  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

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

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Chronic hepatitis C, Ursodeoxycholic acid  

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic
Ursodeoxycholic Acid

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections
Therapeutic Uses
Cholagogues and Choleretics
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008




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