GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

November 26, 2013 updated by: Gilead Sciences

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV Infection (Protocol No. GS US 248 0132)

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GIRI GI Research Institute
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver, British Columbia, Canada, V6Z 2C9
        • University of British Columbia
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
        • University of Manitoba
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital, University Health Network
      • Toronto, Ontario, Canada, M5T2S8
        • Toronto Western Hospital
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital, University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H2X3J4
        • Hospital Saint-Luc DU CHUM
  • Puerto Rico
      • San Juan, Puerto Rico, 00909-1711
        • Clinical Research Puerto Rico Inc
  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • California Liver Institute
      • Coronado, California, United States, 92118
        • SCTI Research Foundation Liver Center
      • La Jolla, California, United States, 92037
        • Scripps Clinic
      • La Jolla, California, United States, 92161
        • University of California, San Diego
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Medical Center
      • Los Angeles, California, United States, 90036
        • Lightsource Medical
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, United States, 92154
        • Kaiser Permanente
      • San Francisco, California, United States, 94115
        • California Pacific Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, Center for Liver Diseases
      • Orlando, Florida, United States, 32803-1851
        • Orlando Immunology Center (ACH)
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia, PC
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Indianapolis Gastroenterology Research Foundation
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deconess Medical Center
      • Springfield, Massachusetts, United States, 01105
        • The Research Institute
    • Michigan
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Saint Michael's Medical Center
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Asheville Gastroenterology Associates, P.A.
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • University Gastroenterology
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
    • Texas
      • Arlington, Texas, United States, 76012
        • The North Texas Research Institute
      • Galveston, Texas, United States, 77555
        • The University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • The University of Texas Health Sciences Center at Houston
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital Center for Liver Diseases
      • Newport News, Virginia, United States, 23602
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult subjects 18 and older with chronic HCV infection
  • Liver biopsy results (performed no more than 3 years prior to Screening) indicating the absence of cirrhosis
  • Monoinfection with HCV genotype 1a or 1b
  • Interferon ineligible or intolerant
  • Body mass index (BMI) between 18 and 40 kg/m2
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male
  • Screening laboratory values within defined thresholds
  • Has not been exposed to any investigational drug or device within 30 days of the Screening visit
  • Able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Exclusion Criteria:

  • Prior treatment of HCV with any direct-acting antiviral (whether approved or experimental)
  • Decompensated liver disease or cirrhosis
  • Co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
  • History of difficulty with blood collection and/or poor venous access
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology
  • Suspicion of hepatocellular carcinoma
  • Clinically-relevant drug abuse

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
GS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
Drug: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
Drug: tegobuvir capsule
tegobuvir capsule, 30 mg BID
Active Comparator: Arm 2
GS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
Drug: tegobuvir capsule
tegobuvir capsule, 30 mg BID
Drug: placebo matching ribavirin tablet
placebo matching ribavirin tablet, BID
Active Comparator: Arm 3
GS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
Drug: ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Drug: GS-5885 tablet
GS-5885 tablet, 90 mg, QD
Drug: GS-9451 tablet
GS-9451 tablet, 200 mg QD
Device: placebo matching tegobuvir capsule
placebo matching tegobuvir capsule, BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: Through 24 weeks of off-treatment follow-up
To evaluate safety and tolerability of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin. Safety will be assessed during the study through the reporting of adverse events, clinical laboratory tests, physical examinations, vital signs and 12-lead ECGs at various time points during the study.
Through 24 weeks of off-treatment follow-up
Antiviral Activity
Time Frame: Through 24 weeks of off-treatment follow-up
To evaluate antiviral efficacy as measured by sustained virologic response (defined as HCV RNA < lower limit of quantitation 24-weeks post-treatment) of combination therapy with GS-5885, GS-9451, tegobuvir and ribavirin or GS-5885, GS-9451 and tegobuvir or GS-5885, GS-9451 and ribavirin.
Through 24 weeks of off-treatment follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Viral Dynamics
Time Frame: Through 10 days of therapy
To characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir. The median change from baseline in HCV RNA and time-weighted average change from baseline through Day 10 will be assessed based on plasma HCV RNA sampling times to characterize the viral dynamics of GS-5885, GS-9451 and tegobuvir.
Through 10 days of therapy
Composite (or Profile) of Pharmacokinetics
Time Frame: predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
To characterize the steady state pharmacokinetics of GS-5885, GS-9451, tegobuvir and ribavirin (if appropriate). Cmax, Tmax, Clast, Tlast, Ctau, λz, AUCtau and T ½
predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Investigators

  • Study Director: John McNally, PhD, 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

September 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 9, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (Estimate)

September 15, 2011

Study Record Updates

Last Update Posted (Estimate)

December 20, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-248-0132

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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