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

Chronic Hepatitis C Clinical Trial

Official title:

A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00200343
• Other study ID #: MT711-01
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: March 7, 2012
• Start date: July 2002
• Est. completion date: December 2004

Study information

• Verified date: March 2012
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Ursodeoxycholic acid 150mg / day
Ursodeoxycholic acid, 150mg/ day, three times a day at meals
• Ursodeoxycholic acid 600mg / day
Ursodeoxycholic acid, 600mg/ day, three times a day at meals
• Ursodeoxycholic acid 900mg / day
Ursodeoxycholic acid, 900mg/ day, three times a day at meals

Locations

Country	Name	City	State
Japan	Department of Gastroenterology, University of Tokyo	hongo, bunkyo-ku, Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Omata M, Yoshida H, Toyota J, Tomita E, Nishiguchi S, Hayashi N, Iino S, Makino I, Okita K, Toda G, Tanikawa K, Kumada H; Japanese C-Viral Hepatitis Network. A large-scale, multicentre, double-blind trial of ursodeoxycholic acid in patients with chronic h — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alanine Aminotransferase at Baseline		0 week	No
Primary	Percentage Change of Alanine Aminotransferase From Baseline at Week 24	Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100	24 weeks (from baseline to Week 24)	No
Secondary	Aspartate Aminotransferase at Baseline		0 week	No
Secondary	Percentage Change of Aspartate Aminotransferase From Baseline at Week 24	Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100	24 weeks (from baseline to Week 24)	No
Secondary	Gamma-glutamyl Transpeptidase at Baseline		0 week	No
Secondary	Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24	Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100	24 weeks (from baseline to Week 24)	No