Back to resultsPEG-IFN Plus Ribavirin Combination Therapy for Older Patients
Primary Purpose
Hepatitis C Virus
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Pegylated interferon alpha-2b plus ribavirin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus focused on measuring Hepatitis C Virus Pegylated Interferon Ribavirin Older
Eligibility Criteria
Inclusion Criteria:
- A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.
- All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.
Exclusion Criteria:
- Clinical or biochemical evidence of hepatic decompensation.
- Advanced cirrhosis identified by large esophageal varices (F2 or F3).
- History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
- Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ.
- Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
- Excessive active alcohol consumption > 60 g/day or drug abuse.
- Severe psychiatric disease.
- Antiviral or corticosteroid therapy within 12 months prior to the enrollment.
Sites / Locations
- Department of General Medicine, Kyushu University HospitalRecruiting
Outcomes
Primary Outcome Measures
antiviral effect by PEG-IFN alpha-2b plus RBV treatment
Secondary Outcome Measures
the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00956982
Brief Title
PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
Official Title
Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2004 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Kyushu University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to analyze the efficacy and safety of a combination therapy of pegylated interferon (PEG-IFN) alpha-2b plus ribavirin (RBV) for older Japanese patients (≧65years old) infected with hepatitis C virus (HCV) compared with younger patients(< 65 years old).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
Keywords
Hepatitis C Virus Pegylated Interferon Ribavirin Older
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1251 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pegylated interferon alpha-2b plus ribavirin
Intervention Description
All patients were treated with a weight-based, 1.5 μg/kg weekly dose of subcutaneous PEG-IFN alpha-2b (PegIntron A, Schering-Plough, Osaka, Japan), in combination with PEG-IFN alpha-2b, RBV (Rebetol; Schering-Plough), which was given orally at a daily dose of 600-1000mg based on bodyweight (600 mg for patients weighing < 60 kg, 800 mg for those weighing 60-80 kg, and 1000 mg for those weighing 80 kg). The length of treatment was 48 weeks for patients with HCV of genotype 1and 24 weeks for patients with genotypes 2, respectively
Primary Outcome Measure Information:
Title
antiviral effect by PEG-IFN alpha-2b plus RBV treatment
Time Frame
24-weeks follow-up after the end of treatment
Secondary Outcome Measure Information:
Title
the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment
Time Frame
during PEG-IFN alpha-2b plus RBV treatment (48 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A prospective study of 2270 Japanese patients aged 18 years or older treated with PEG-IFN alpha-2b plus RBV was done between December 2004 and July 2008.
All positive for both antibody to HCV and HCV-RNA for over six months and were enrolled.
Exclusion Criteria:
Clinical or biochemical evidence of hepatic decompensation.
Advanced cirrhosis identified by large esophageal varices (F2 or F3).
History of gastrointestinal bleeding, ascites, encephalopathy, or hepatocellular carcinoma.
Hemoglobin level < 11.5g/L, white blood cell count < 3×10９/Ｌ，and platelet count < 50×10９/Ｌ.
Concomitant liver disease other than hepatitis C(hepatitis B surface antigen positive or HIV positive).
Excessive active alcohol consumption > 60 g/day or drug abuse.
Severe psychiatric disease.
Antiviral or corticosteroid therapy within 12 months prior to the enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Hayashi
Phone
+81-92-642-5909
Email
hayashij@genmedpr.med.kyushu-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Hayashi
Organizational Affiliation
Department of General Medicine, Kyushu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General Medicine, Kyushu University Hospital
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mosaburo Kainuma
Phone
+81-92-642-5909
Email
kainuma@genmedpr.med.kyushu-u.ac.jp
First Name & Middle Initial & Last Name & Degree
Jun Hayashi
12. IPD Sharing Statement
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PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
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