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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Ursodeoxycholic acid 150mg / day
* Drug: Ursodeoxycholic acid 600mg / day
* Drug: Ursodeoxycholic acid 900mg / day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ursodeoxycholic acid 150mg / day<br> | Drug: Ursodeoxycholic acid 150mg / day<br>* Ursodeoxycholic acid, 150mg/ day, three times a day at meals<br>|
| Experimental: Ursodeoxycholic acid 600mg / day<br> | Drug: Ursodeoxycholic acid 600mg / day<br>* Ursodeoxycholic acid, 600mg/ day, three times a day at meals<br>|
| Experimental: Ursodeoxycholic acid 900mg / day<br> | Drug: Ursodeoxycholic acid 900mg / day<br>* Ursodeoxycholic acid, 900mg/ day, three times a day at meals<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alanine Aminotransferase at Baseline |  | 0 week | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aspartate Aminotransferase at Baseline |  | 0 week | 
| 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) | 
| Gamma-glutamyl Transpeptidase at Baseline |  | 0 week | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, Ursodeoxycholic acid