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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 245

Last updated 2014-02-06

No results posted yet for this study

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®).

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Tegobuvir (GS-9190)

Tegobuvir (GS-9190) capsule, 30 mg BID

DRUG

GS-9451

GS-9451 tablet, 200 mg once daily (QD)

BIOLOGICAL

Pegasys®

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

DRUG

Copegus®

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

DRUG

GS-9451

GS-9451 tablet, 200 mg QD

DRUG

Tegobuvir placebo

placebo matching Tegobuvir (GS-9190) capsule BID

BIOLOGICAL

Pegasys®

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

DRUG

Copegus®

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

DRUG

Tegobuvir placebo

placebo matching Tegobuvir (GS-9190) capsule BID

DRUG

GS-9451 placebo

placebo matching GS-9451 tablet QD

BIOLOGICAL

Pegasys®

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

DRUG

Copegus®

ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet

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
  • France
  • Germany
  • Netherlands
  • Poland
  • 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 NCT01271790 on ClinicalTrials.gov