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

This study has been completed.
Sponsor:
Information provided by:
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00200343
First received: September 12, 2005
Last updated: March 7, 2012
Last verified: March 2012

September 12, 2005
March 7, 2012
July 2002
Not Provided
  • 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
serum alanine aminotransferase levels at 24-week of treatment
Complete list of historical versions of study NCT00200343 on ClinicalTrials.gov Archive Site
  • 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
serum aspartate aminotransferase and gamma-glutamyltranspeptidase) levels at 24-week of treatment
Not Provided
Not Provided
 
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
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Ursodeoxycholic acid 150mg / day
    Ursodeoxycholic acid, 150mg/ day, three times a day at meals
  • Drug: Ursodeoxycholic acid 600mg / day
    Ursodeoxycholic acid, 600mg/ day, three times a day at meals
  • Drug: Ursodeoxycholic acid 900mg / day
    Ursodeoxycholic acid, 900mg/ day, three times a day at meals
  • Experimental: Ursodeoxycholic acid 150mg / day
    Intervention: Drug: Ursodeoxycholic acid 150mg / day
  • Experimental: Ursodeoxycholic acid 600mg / day
    Intervention: Drug: Ursodeoxycholic acid 600mg / day
  • Experimental: Ursodeoxycholic acid 900mg / day
    Intervention: Drug: Ursodeoxycholic acid 900mg / day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
596
December 2004
Not Provided

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
Not Provided
Not Provided
Mitsubishi Tanabe Pharma Corporation
Not Provided
Study Chair: Masao Omata, MD Department of Gastroenterology, University of Tokyo
Mitsubishi Tanabe Pharma Corporation
March 2012

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