PEG-IFN Plus Ribavirin Combination Therapy for Older Patients

NCT ID: NCT00956982

Last Updated: 2009-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1251 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2012-12-31

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).

Conditions

Hepatitis C Virus

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyushu University

OTHER

Sponsor Role: lead

Responsible Party

Department of General Medicine, Kyushu University Hospital

Principal Investigators

Jun Hayashi

Role: PRINCIPAL_INVESTIGATOR

Department of General Medicine, Kyushu University Hospital

Locations

Department of General Medicine, Kyushu University Hospital

Fukuoka, , Japan

Site Status: RECRUITING

Countries

Japan

Central Contacts

Jun Hayashi

Role: CONTACT

hayashij@genmedpr.med.kyushu-u.ac.jp

+81-92-642-5909

Facility Contacts

Mosaburo Kainuma

Role: primary

kainuma@genmedpr.med.kyushu-u.ac.jp

+81-92-642-5909

Other Identifiers

KULDS2009

Identifier Type: -

Identifier Source: org_study_id