Comparative Trial of Standard Versus Low-dose Peg-Interferon Plus Ribavirin in the Treatment of Chronic Hepatitis C

Completed

• Conditions: Hepatitis C, Chronic

• Registration Number: NCT00216775
• Lead Sponsor: Kyoto University

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of low-dose interferon-alfa-2b plus ribavirin compared to the standard-dose of the same combination in patients with chronic hepatitis C.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-22
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-01
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Clinical diagnosis of Chronic Hepatitis C. Must be infected with genotype 1b viruses

Exclusion Criteria

• Hemoglobin levels<8.5g/dL,
• Platelet counts<50,000/mm3,
• Total polymorphonuclear counts<1000/mm3
• Pregnancy,
• Renal dysfunction,

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
rate of sustained viral response	6 months

Trial Locations

Locations (4)

Department of Gastroenterology and Hepatology, Kyoto University Hospital; 🇯🇵 Kyoto, Japan

Kitano Hospital; 🇯🇵 Osaka, Japan

Osaka Red Cross Hospital; 🇯🇵 Osaka, Japan

Wakayama Red Cross Hospital; 🇯🇵 Wakayama, Japan