PEG-IFN Plus Ribavirin Combination Therapy for Older Patients
Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C
1 other identifier
interventional
1,251
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 6, 2009
CompletedFirst Posted
Study publicly available on registry
August 11, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedAugust 11, 2009
August 1, 2009
3.6 years
August 6, 2009
August 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
antiviral effect by PEG-IFN alpha-2b plus RBV treatment
24-weeks follow-up after the end of treatment
Secondary Outcomes (1)
the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment
during PEG-IFN alpha-2b plus RBV treatment (48 weeks)
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of General Medicine, Kyushu University Hospital
Fukuoka, 812-8582, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jun Hayashi
Department of General Medicine, Kyushu University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 6, 2009
First Posted
August 11, 2009
Study Start
December 1, 2004
Primary Completion
July 1, 2008
Study Completion
December 1, 2012
Last Updated
August 11, 2009
Record last verified: 2009-08