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Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
This study has been completed.
Study NCT00200343   Information provided by Mitsubishi Tanabe Pharma Corporation
First Received: September 12, 2005   No Changes Posted

September 12, 2005
September 12, 2005
July 2002
 
serum alanine aminotransferase levels at 24-week of treatment
Same as current
No Changes Posted
serum aspartate aminotransferase and gamma-glutamyltranspeptidase) levels at 24-week of treatment
Same as current
 
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
A 24-Week Multicenter Double-Blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C

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.

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.

 
Interventional
Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Chronic Hepatitis C
Drug: Ursodeoxycholic acid
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
600
December 2004
 

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
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00200343
 
MT711-01
Mitsubishi Tanabe Pharma Corporation
 
Study Chair: Masao Omata, MD Department of Gastroenterology, University of Tokyo
Mitsubishi Tanabe Pharma Corporation
September 2005

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