drugset / Trial / NCT01271790

A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

NCT01271790

Phase 2 Completed 245 enrolled Gilead Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tegobuvir Small molecule 30 mg Oral
Comparator vedroprevir Small molecule 200 mg Oral
Comparator Peginterferon alfa-2a Protein / enzyme biologic 180 ug Other
Comparator Ribavirin Small molecule 500 mg Oral
Comparator Ribavirin Small molecule 600 mg Oral