drugset / Trial / NCT01225380

A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

NCT01225380

Phase 2 Completed 324 enrolled Gilead Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

Timeline

Start
2010-10
Primary completion
2013-01
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Subject GS-9256 Small molecule 150 mg
Subject Tegobuvir Small molecule 20 mg
Comparator Peginterferon alfa-2a Protein / enzyme biologic 180 ug Other
Comparator Ribavirin Small molecule 1000 mg
Comparator Ribavirin Small molecule 1200 mg