PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956982

Enrollment

1251

Registered

2009-08-11

Start date

2004-12-31

Completion date

2012-12-31

Last updated

2009-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Virus

Keywords

Hepatitis C Virus Pegylated Interferon Ribavirin Older

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).

Interventions

DRUGPegylated 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
the tolerance of older patients by PEG-IFN alpha-2b plus RBV treatment	during PEG-IFN alpha-2b plus RBV treatment (48 weeks)

Countries

Japan

Contacts

Primary ContactJun Hayashi

hayashij@genmedpr.med.kyushu-u.ac.jp+81-92-642-5909

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026