Back to resultsEfficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
Primary Purpose
Chronic Hepatitis C
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Ursodeoxycholic acid 150mg / day
Ursodeoxycholic acid 600mg / day
Ursodeoxycholic acid 900mg / day
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C focused on measuring Chronic hepatitis C, Ursodeoxycholic acid
Eligibility Criteria
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
Sites / Locations
- Department of Gastroenterology, University of Tokyo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Ursodeoxycholic acid 150mg / day
Ursodeoxycholic acid 600mg / day
Ursodeoxycholic acid 900mg / day
Arm Description
Outcomes
Primary Outcome Measures
Alanine Aminotransferase at Baseline
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
Secondary Outcome Measures
Aspartate Aminotransferase at Baseline
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
Gamma-glutamyl Transpeptidase at Baseline
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
Full Information
NCT ID
NCT00200343
First Posted
September 12, 2005
Last Updated
March 7, 2012
Sponsor
Mitsubishi Tanabe Pharma Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00200343
Brief Title
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
Official Title
A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C
Keywords
Chronic hepatitis C, Ursodeoxycholic acid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
596 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ursodeoxycholic acid 150mg / day
Arm Type
Experimental
Arm Title
Ursodeoxycholic acid 600mg / day
Arm Type
Experimental
Arm Title
Ursodeoxycholic acid 900mg / day
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid 150mg / day
Intervention Description
Ursodeoxycholic acid, 150mg/ day, three times a day at meals
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid 600mg / day
Intervention Description
Ursodeoxycholic acid, 600mg/ day, three times a day at meals
Intervention Type
Drug
Intervention Name(s)
Ursodeoxycholic acid 900mg / day
Intervention Description
Ursodeoxycholic acid, 900mg/ day, three times a day at meals
Primary Outcome Measure Information:
Title
Alanine Aminotransferase at Baseline
Time Frame
0 week
Title
Percentage Change of Alanine Aminotransferase From Baseline at Week 24
Description
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Time Frame
24 weeks (from baseline to Week 24)
Secondary Outcome Measure Information:
Title
Aspartate Aminotransferase at Baseline
Time Frame
0 week
Title
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
Description
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Time Frame
24 weeks (from baseline to Week 24)
Title
Gamma-glutamyl Transpeptidase at Baseline
Time Frame
0 week
Title
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
Description
Percentage change=[(measured value at Week 24 - measured value at baseline)/measured value at baseline]*100
Time Frame
24 weeks (from baseline to Week 24)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masao Omata, MD
Organizational Affiliation
Department of Gastroenterology, University of Tokyo
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gastroenterology, University of Tokyo
City
hongo, bunkyo-ku, Tokyo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
17573387
Citation
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 hepatitis C. Gut. 2007 Dec;56(12):1747-53. doi: 10.1136/gut.2007.120956. Epub 2007 Jun 15.
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Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
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