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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2014-01-28

No results posted yet for this study

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.

Conditions

  • Chronic Hepatitis C Infection

Interventions

DRUG

GS-9190

GS-9190 capsule, 20 mg BID, 16 or 24 weeks

DRUG

GS-9256

GS-9256 capsule, 150 mg BID, 16 or 24 weeks

BIOLOGICAL

Pegasys®

peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks

DRUG

Copegus®

ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks

DRUG

GS-9190 placebo

placebo matching GS-9190 capsule BID, 24 weeks

DRUG

GS-9256

GS-9256 capsule, 150 mg BID, 24 weeks

BIOLOGICAL

Pegasys®

peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks

DRUG

Copegus®

ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks

DRUG

GS-9190 placebo

placebo matching GS-9190 capsule BID, 24 weeks

DRUG

GS-9256 placebo

placebo matching GS-9256 capsule BID, 24 weeks

BIOLOGICAL

Pegasys®

peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks

DRUG

Copegus®

ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), 48 weeks

Sponsors & Collaborators

Principal Investigators

  • Bittoo Kanwar · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2013-01-31
Completion
2013-09-30

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01225380 on ClinicalTrials.gov