NCT01384383

GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 248 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	GS-5885	GS-5885 30 mg tablet administered orally once daily
DRUG	GS-9451	GS-9451 200 mg tablet administered orally once daily
DRUG	RBV	Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUG	PEG	Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2011-06-29
• Last updated: 2014-02-03

Locations

55 sites across 4 countries: United States, Australia, Canada, New Zealand