NCT00956982

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,251 (estimated)
• Sponsor: Kyushu University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-12-01
• Primary completion: 2008-07-01
• Completion: 2012-12-01
• First posted: 2009-08-11
• Last updated: 2009-08-11

Locations

1 site across 1 country: Japan