drugset / Trial / NCT00351403

Individually Adapted Therapy Duration for the Treatment of Chronic Hepatitis C Genotype 1 Infection

NCT00351403

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Patients with chronic hepatitis C genotype 1 virus infection are usually treated with Interferon alfa plus Ribavirin over 48 weeks. For some patients this might be too long, for others too short. An individually adapted therapy length from 24 to 72 weeks will be determined in dependence of the initial virus load and the time to HCV RNA negativity. The primary objective is to compare the cumulative rate of the sustained viral response (SVR) of the patients with the individually adapted therapy duration to the SVR rates of a historic patient collective under the 48 week standard therapy.

Timeline

Start
2006-07
Primary completion
2010-01
Completion
2010-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 50 ug Other
Subject Peginterferon alfa-2b Protein / enzyme biologic 80 ug Other
Subject Peginterferon alfa-2b Protein / enzyme biologic 100 ug Other
Subject Peginterferon alfa-2b Protein / enzyme biologic 120 ug Other
Subject Peginterferon alfa-2b Protein / enzyme biologic 150 ug Other
Subject Ribavirin Small molecule 200 mg