- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00200343
Efficacy and Safety Study of Ursodeoxycholic Acid to Treat Chronic Hepatitis C
March 7, 2012 updated by: Mitsubishi Tanabe Pharma Corporation
A 24-week Multicenter Double-blind Control Trial With Ursodeoxycholic Acid in Patients With Chronic Hepatitis C
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
596
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
hongo, bunkyo-ku, Tokyo, Japan
- Department of Gastroenterology, University of Tokyo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ursodeoxycholic acid 150mg / day
|
Ursodeoxycholic acid, 150mg/ day, three times a day at meals
|
Experimental: Ursodeoxycholic acid 600mg / day
|
Ursodeoxycholic acid, 600mg/ day, three times a day at meals
|
Experimental: Ursodeoxycholic acid 900mg / day
|
Ursodeoxycholic acid, 900mg/ day, three times a day at meals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alanine Aminotransferase at Baseline
Time Frame: 0 week
|
0 week
|
|
Percentage Change of Alanine Aminotransferase From Baseline at Week 24
Time Frame: 24 weeks (from baseline to 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
Time Frame: 0 week
|
0 week
|
|
Percentage Change of Aspartate Aminotransferase From Baseline at Week 24
Time Frame: 24 weeks (from baseline to 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
Time Frame: 0 week
|
0 week
|
|
Percentage Change of Gamma-glutamyl Transpeptidase From Baseline at Week 24
Time Frame: 24 weeks (from baseline to 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Masao Omata, MD, Department of Gastroenterology, University of Tokyo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2002
Study Completion
December 1, 2004
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 20, 2005
Study Record Updates
Last Update Posted (Estimate)
March 12, 2012
Last Update Submitted That Met QC Criteria
March 7, 2012
Last Verified
March 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Gastrointestinal Agents
- Cholagogues and Choleretics
- Ursodeoxycholic Acid
Other Study ID Numbers
- MT711-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Hepatitis C
-
Sohag UniversityRecruiting
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi...Recruiting
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis cChina
-
Ascletis Pharmaceuticals Co., Ltd.CompletedChronic Hepatitis cChina
-
Hospices Civils de LyonCompleted
-
Beijing Kawin Technology Share-Holding Co., Ltd.CompletedChronic Hepatitis cChina
Clinical Trials on Ursodeoxycholic acid 150mg / day
-
University of Sao Paulo General HospitalCompletedPrimary Biliary Cirrhosis | Ursodeoxycholic AcidBrazil
-
University of TennesseeUniversity of Colorado, Denver; Baylor College of Medicine; Children's Hospital... and other collaboratorsCompletedPrimary Sclerosing CholangitisUnited States
-
West China HospitalUnknownHepatitis | Autoimmune | Primary Biliary CholangitisChina
-
Daewoong Pharmaceutical Co. LTD.CompletedHealthy SubjectKorea, Democratic People's Republic of
-
Institute of Hematology & Blood Diseases HospitalCompleted
-
Turku University HospitalCompletedPregnancy | Intrahepatic CholestasisFinland
-
Nottingham University Hospitals NHS TrustTerminated
-
HaEmek Medical Center, IsraelUnknown
-
Tanta UniversityMenoufia UniversityRecruiting
-
University of MinnesotaCompletedParkinson DiseaseUnited States