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PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Kyushu University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Kyushu University
ClinicalTrials.gov Identifier:
NCT00956982
First received: August 6, 2009
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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) ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00956982

Contacts
Contact: Jun Hayashi +81-92-642-5909 hayashij@genmedpr.med.kyushu-u.ac.jp

Locations
Japan
Department of General Medicine, Kyushu University Hospital Recruiting
Fukuoka, Japan, 812-8582
Contact: Mosaburo Kainuma    +81-92-642-5909    kainuma@genmedpr.med.kyushu-u.ac.jp   
Principal Investigator: Jun Hayashi         
Sponsors and Collaborators
Kyushu University
Investigators
Principal Investigator: Jun Hayashi Department of General Medicine, Kyushu University Hospital
  More Information

No publications provided

Responsible Party: Jun Hayashi, Department of General Medicine, Kyushu University Hospital
ClinicalTrials.gov Identifier: NCT00956982     History of Changes
Other Study ID Numbers: KULDS2009
Study First Received: August 6, 2009
Last Updated: August 10, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2b
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014