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

Phase 3

Completed

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Ursodeoxycholic acid 150mg / day; Drug: Ursodeoxycholic acid 600mg / day; Drug: Ursodeoxycholic acid 900mg / day

• Registration Number: NCT00200343
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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 verify the superiority of efficacy of UDCA 600 or 900mg/day to that of 150mg/day and the safety of UDCA treatment.

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.

Study Timeline

• Study Start: 2002-07
• Study Completion: 2004-12
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-20
• Results First Submitted: 2011-08-17
• Results First Submitted QC: 2011-09-29
• Results First Posted: 2011-11-06
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ursodeoxycholic acid 150mg / day	Ursodeoxycholic acid 150mg / day	-
Ursodeoxycholic acid 600mg / day	Ursodeoxycholic acid 600mg / day	-
Ursodeoxycholic acid 900mg / day	Ursodeoxycholic acid 900mg / day	-

Primary Outcome Measures

Name	Time	Method
Alanine Aminotransferase at Baseline	0 week
Percentage Change of Alanine Aminotransferase From Baseline at Week 24	24 weeks (from baseline to Week 24)	Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Secondary Outcome Measures

Name	Time	Method
Aspartate Aminotransferase at Baseline	0 week
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24	24 weeks (from baseline to Week 24)	Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100
Gamma-glutamyl Transpeptidase at Baseline	0 week
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24	24 weeks (from baseline to Week 24)	Percentage change=\[(measured value at Week 24 - measured value at baseline)/measured value at baseline\]\*100

Trial Locations

Locations (1)

Department of Gastroenterology, University of Tokyo; 🇯🇵 hongo, bunkyo-ku, Tokyo, Japan