PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

August 10, 2009 updated by: Kyushu University

Pegylated Interferon Alpha-2b Plus Ribavirin Combination Treatment for Older Patients With Chronic Hepatitis C

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1251

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Department of General Medicine, Kyushu University Hospital
        • Contact:
        • Principal Investigator:
          • Jun Hayashi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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)
during PEG-IFN alpha-2b plus RBV treatment (48 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyushu University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

July 1, 2008

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

August 6, 2009

First Submitted That Met QC Criteria

August 10, 2009

First Posted (Estimate)

August 11, 2009

Study Record Updates

Last Update Posted (Estimate)

August 11, 2009

Last Update Submitted That Met QC Criteria

August 10, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KULDS2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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