Status:
COMPLETED
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2004
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT00200343
Start Date
July 1 2002
End Date
December 1 2004
Last Update
January 7 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Gastroenterology, University of Tokyo
Hongo, Bunkyo-ku, Tokyo, Japan