A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype

NCT01384383 Phase 2 TERMINATED

This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451 + PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC genotype.

Details

Lead sponsor	Gilead Sciences
Phase	Phase 2
Status	TERMINATED
Enrolment	248
Start date	2011-08
Completion	2013-06

Conditions

• Chronic Hepatitis C

Interventions

• GS-5885
• GS-9451
• RBV
• PEG

Primary outcomes

• Sustained virologic response (SVR) — 30 , 36 or 48 weeks
  Sustained virologic response (SVR, defined as plasma HCV RNA \< lower limit of quantification \[LLoQ\] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.

Countries

United States, Australia, Canada, New Zealand