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Trial record 6 of 540 for:    IFNA2 AND RBV AND IFN alfa-2

PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00956982
Recruitment Status : Unknown
Verified August 2009 by Kyushu University.
Recruitment status was:  Recruiting
First Posted : August 11, 2009
Last Update Posted : August 11, 2009
Information provided by:
Kyushu University

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).

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Drug: Pegylated interferon alpha-2b plus ribavirin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1251 participants
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
Study Start Date : December 2004
Actual Primary Completion Date : July 2008
Estimated Study Completion Date : December 2012

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

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

Secondary Outcome Measures :
  1. 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) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00956982

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

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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
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Principal Investigator: Jun Hayashi Department of General Medicine, Kyushu University Hospital

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Responsible Party: Jun Hayashi, Department of General Medicine, Kyushu University Hospital Identifier: NCT00956982     History of Changes
Other Study ID Numbers: KULDS2009
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009
Keywords provided by Kyushu University:
Hepatitis C Virus Pegylated Interferon Ribavirin Older
Additional relevant MeSH terms:
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Interferon alpha-2
Peginterferon alfa-2b
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs