GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus

January 2, 2014 updated by: Gilead Sciences

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy With GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection

This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

351

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • Beverly Hills, California, United States, 90211
      • Coronado, California, United States, 92118
      • Costa Mesa, California, United States, 92626
      • San Diego, California, United States, 92123
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Englewood, Colorado, United States, 80110
    • Florida
      • Bradenton, Florida, United States, 34209
    • Maryland
      • Baltimore, Maryland, United States, 21229
      • Baltimore, Maryland, United States, 21202
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
    • Missouri
      • Kansas City, Missouri, United States, 64131
    • New York
      • Forest Hills, New York, United States, 11375
      • Manhasset, New York, United States, 11030
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Tennessee
      • Nashville, Tennessee, United States, 37211
    • Texas
      • Arlington, Texas, United States, 76012
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78215
    • Virginia
      • Fairfax, Virginia, United States, 22031

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females 18-70 years of age
  • Chronic HCV infection
  • Subjects must have liver biopsy results (≤ 2 years prior to Screening) indicating the absence of cirrhosis.
  • Monoinfection with HCV genotype 1
  • HCV RNA > 10^4 IU/mL at Screening
  • HCV treatment naïve
  • Candidate for PEG/RBV therapy
  • Body mass index (BMI) 18-36 kg/m2, inclusive
  • Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline.

Exclusion Criteria:

  • Pregnant female or male with pregnant female partner
  • Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)
  • Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
  • Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1
RGT with GS-5885 30 mg QD + GS-9451 200 mg QD + PEG/RBV
Drug: GS-5885
tablet, 30 mg QD
Drug: GS-9451
tablet, 200 mg QD
Biological: peginterferon alfa-2a
(solution for injection) 180 µg/week
Drug: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
PLACEBO_COMPARATOR: Arm 2
RGT with GS-5885 30 mg QD + GS-9451 placebo QD + PEG/RBV
Drug: GS-5885
tablet, 30 mg QD
Biological: peginterferon alfa-2a
(solution for injection) 180 µg/week
Drug: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Drug: GS-9451 Placebo
Placebo to match GS-9451 QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the antiviral efficacy of response guided therapy.
Time Frame: Through 24 weeks post-treatment
To evaluate the antiviral efficacy as measured by sustained virologic response (SVR, defined as plasma HCV RNA < Lower Limit of Quantification (LLoQ) at 24 weeks post-treatment) of response guided therapy (RGT) with GS-5885 + GS-9451 + PEG/RBV, or GS-5885 + PEG/RBV.
Through 24 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the safety and tolerability of each regimen.
Time Frame: Through 24 weeks post-treatment
The primary safety endpoint is any AE leading to permanent discontinuation of study drugs.
Through 24 weeks post-treatment
To characterize viral dynamics of GS-5885 and GS-9451 when administered with PEG and RBV.
Time Frame: Through Day 10 on study
HCV RNA levels, pharmacokinetics and viral sequencing
Through Day 10 on study
To characterize the viral resistance to GS-5885 and GS-9451 when administered in combination with PEG and RBV.
Time Frame: 12 or 24 weeks
Plasma samples will be collected and stored at each visit for possible resistance analysis.
12 or 24 weeks
To characterize steady state pharmacokinetics of GS-5885 and GS-9451 when administered with PEG and RBV.
Time Frame: Through 48 weeks of treatment
Plasma concentrations of the study drug over time will be summarized using descriptive statistics.
Through 48 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (ESTIMATE)

May 19, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-256-0148

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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