drugset / Trial / NCT00152581

Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication

NCT00152581

Phase 4 Completed 40 enrolled University College London Hospitals
RandomizedParallel-groupOpen-labelTreatment

Summary

Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 - 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Followed-up for 24 weeks after treatment cessation. Objectives: 1. To determine the necessary duration of combination treatment with Pegylated-Interferon alfa2a (PEGASYS) \& Ribavirin in Patients infected with genotype 1, in order to achieve viral clearance 2. To identify host factors, which are associated with different patterns of virological response to combination treatment (fast responder, slow responder, non-responder). On this basis, to identify possible predictors for the duration of antiviral treatment.

Timeline

Start
2002-04
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 mg
Subject Ribavirin Small molecule 1000 mg
Subject Ribavirin Small molecule 1200 mg