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PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Kyushu University.
Recruitment status was:  Recruiting
Information provided by:
Kyushu University Identifier:
First received: August 6, 2009
Last updated: August 10, 2009
Last verified: August 2009
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).

Condition Intervention
Hepatitis C Virus Drug: Pegylated interferon alpha-2b plus ribavirin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C

Resource links provided by NLM:

Further study details as provided by Kyushu University:

Primary Outcome Measures:
  • antiviral effect by PEG-IFN alpha-2b plus RBV treatment [ Time Frame: 24-weeks follow-up after the end of treatment ]

Secondary Outcome Measures:
  • 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) ]

Estimated Enrollment: 1251
Study Start Date: December 2004
Estimated Study Completion Date: December 2012
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Pegylated interferon alpha-2b plus ribavirin
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00956982

Contact: Jun Hayashi +81-92-642-5909

Department of General Medicine, Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Contact: Mosaburo Kainuma    +81-92-642-5909   
Principal Investigator: Jun Hayashi         
Sponsors and Collaborators
Kyushu University
Principal Investigator: Jun Hayashi Department of General Medicine, Kyushu University Hospital
  More Information

Responsible Party: Jun Hayashi, Department of General Medicine, Kyushu University Hospital Identifier: NCT00956982     History of Changes
Other Study ID Numbers: KULDS2009
Study First Received: August 6, 2009
Last Updated: August 10, 2009

Keywords provided by Kyushu University:
Hepatitis C Virus Pegylated Interferon Ribavirin Older

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017