NCT00629824

Pegylated Interferon Plus Ribavirin in Treating Older Patients With Chronic Hepatitis C

Efficacy and Safety of Pegylated Interferon Plus Ribavirin Combination Therapy in Treating Older Patients With Chronic Hepatitis C

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital · Academic / Other
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Combination therapy with pegylated interferon-alpha plus ribavirin has greatly improved the treatment efficacy and is the mainstream of treatment for chronic hepatitis C infection. The efficacy and safety of pegylated interferon-alpha plus ribavirin combination therapy and its impact on the outcome in older patients with chronic hepatitis C deserve to be elucidated. The purposes of this study are: 1. To evaluate the efficacy of pegylated interferon-alpha 2a plus ribavirin combination therapy in older patients with chronic hepatitis C 2. To investigate the safety of pegylated interferon-alpha 2a plus ribavirin combination therapy in older patients with chronic hepatitis C

Detailed description

A prospective, hospital-based, case-control study enrolling 70 chronic hepatitis C patients who are 65 to 80 years of age and other sex- and HCV genotype-matched 140 chronic hepatitis C patients who are 50 to 64 years of age will be conducted for comparison. The 210 patients chronic hepatitis C patients will receive pegylated interferon-alpha plus ribavirin combination therapy. Genotype 1 infected patients will received 48 weeks of treatment and genotype non-1 patients will received 24 weeks of treatment. Another 40 HCV-1 infected patients who are 65-80 years of age and have a rapid virological response ( defined as seronegative of HCV RNA at week 4 of treatment) will receive 24 weeks of treatment and are enrolled for comparison since Jan 2008. The primary outcome measurement is sustained virological response and safety.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	pegylated interferon alpha and plus ribavirin	pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
DRUG	pegylated interferon alpha and plus ribavirin	pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day, 24weeks of treatment for genotype non-1 infected patients and 48 weeks of treatment for genotype 1 infected patients, follow up for 24 weeks
DRUG	pegylated interferon alpha and plus ribavirin	pegylated interferon alpha 180 ug/week and ribavirin 1000-1200 mg/day for 24 weeks

Timeline

• Start date: 2007-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2008-03-06
• Last updated: 2010-09-08

Locations

1 site across 1 country: Taiwan