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
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)
1 other identifier
interventional
163
3 countries
50
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
Shorter than P25 for phase_2
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 9, 2011
CompletedFirst Posted
Study publicly available on registry
September 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedDecember 20, 2013
November 1, 2013
1.3 years
September 9, 2011
November 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Safety and Tolerability
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
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 Outcomes (2)
Viral Dynamics
Through 10 days of therapy
Composite (or Profile) of Pharmacokinetics
predose, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose
Study Arms (3)
Arm 1
ACTIVE COMPARATORGS-5885, GS-9451, tegobuvir (GS-9190), and Copegus® for 24 weeks
Arm 2
ACTIVE COMPARATORGS-5885, GS-9451, tegobuvir (GS-9190), and a placebo matching ribavirin for 24 weeks
Arm 3
ACTIVE COMPARATORGS-5885, GS-9451, a placebo matching tegobuvir, and Copegus® for 24 weeks
Interventions
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (50)
California Liver Institute
Beverly Hills, California, 90211, United States
SCTI Research Foundation Liver Center
Coronado, California, 92118, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of California, San Diego
La Jolla, California, 92161, United States
Kaiser Permanente Medical Center
Los Angeles, California, 90027, United States
Lightsource Medical
Los Angeles, California, 90036, United States
Medical Associates Research Group, Inc.
San Diego, California, 92123, United States
Kaiser Permanente
San Diego, California, 92154, United States
California Pacific Medical Center
San Francisco, California, 94115, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Miami, Center for Liver Diseases
Miami, Florida, 33136, United States
Orlando Immunology Center (ACH)
Orlando, Florida, 32803-1851, United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deconess Medical Center
Boston, Massachusetts, 02215, United States
The Research Institute
Springfield, Massachusetts, 01105, United States
Henry Ford Health System
Novi, Michigan, 48377, United States
Saint Michael's Medical Center
Newark, New Jersey, 07102, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Gastro One
Germantown, Tennessee, 38138, United States
The North Texas Research Institute
Arlington, Texas, 76012, United States
The University of Texas Medical Branch
Galveston, Texas, 77555, United States
The University of Texas Health Sciences Center at Houston
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, 22042, United States
Bon Secours St. Mary's Hospital of Richmond, Inc.
Newport News, Virginia, 23602, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
University of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University Of Alberta Hospital
Edmonton, Alberta, T6G 2C8, Canada
University of Alberta
Edmonton, Alberta, T6G 2X8, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9, Canada
University of British Columbia
Vancouver, British Columbia, V6Z 2C9, Canada
GIRI GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
University of Manitoba
Winnipeg, Manitoba, R3E 3P4, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6, Canada
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4, Canada
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2N2, Canada
Toronto Western Hospital
Toronto, Ontario, M5T2S8, Canada
Hospital Saint-Luc DU CHUM
Montreal, Quebec, H2X3J4, Canada
Clinical Research Puerto Rico Inc
San Juan, 00909-1711, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John McNally, PhD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2011
First Posted
September 15, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
December 20, 2013
Record last verified: 2013-11