GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
A Phase 2 Randomized, Open-Label Study of GS-5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) to Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection
1 other identifier
interventional
141
2 countries
43
Brief Summary
The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and tolerable in the treatment of Chronic Genotype 1 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 May 2011
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2011
CompletedStudy Start
First participant enrolled
May 1, 2011
CompletedFirst Posted
Study publicly available on registry
May 13, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedDecember 20, 2013
November 1, 2013
1.4 years
April 22, 2011
November 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained virologic response (SVR)
24 weeks of off-treatment follow-up
Secondary Outcomes (6)
Safety and tolerability
through 24 weeks of off-treatment follow-up
HCV RNA < Lower Limit Of Quantification
Weeks 1, 2, 4, 12 and 24
Rescue Therapy Substudy SVR
24 Weeks
Emergence of viral resistance
12 or 24 weeks
Viral dynamics of GS-5885, GS-9451 and Tegobuvir when administered in combination with RBV
Through Week 2 of therapy
- +1 more secondary outcomes
Study Arms (2)
Arm 1
ACTIVE COMPARATORGS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 24 weeks.
Arm 2
ACTIVE COMPARATORGS-5885, GS-9451 and Tegobuvir in combination with ribavirin (Copegus®) for 12 or 24 weeks.
Interventions
(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 to 70 years of age
- Chronic HCV infection for at least 6 months prior to Baseline (Day 1)
- Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis
- Monoinfection with HCV genotype 1a or 1b
- HCV treatment-naĂ¯ve
- Body mass index (BMI) between 18 and 36 kg/m2
- Creatinine clearance ≥ 50 mL/min
- Subject agrees to use highly effective contraception methods if female of childbearing potential or sexually active male.
- Screening laboratory values within defined thresholds
You may not qualify if:
- Autoimmune disease
- Decompensated liver disease or cirrhosis
- Poorly controlled diabetes mellitus
- Severe psychiatric illness
- Severe chronic obstructive pulmonary disease (COPD)
- Serological evidence of co-infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or another HCV genotype
- Suspicion of hepatocellular carcinoma or other malignancy (with exception of certain skin cancers)
- History of hemoglobinopathy
- Known retinal disease
- Subjects who are immunosuppressed
- Subjects with known, current use of amphetamines, cocaine, opiates (i.e., morphine, heroin), methadone, or ongoing alcohol abuse
- Subjects must have no history of clinically significant cardiac disease, including a family history of Long QT syndrome, and no relevant electrocardiogram (ECG) abnormalities at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (43)
Birmingham Gastroenterology Associates, P.C.
Birmingham, Alabama, 35209, United States
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Southern California Liver Centers
Coronado, California, 92118, United States
UCSF Fresno Medical Education Program (MEP)
Fresno, California, 93721, United States
Stanford University School of Medicine
Palo Alto, California, 94304, United States
University of California San Diego
San Diego, California, 92103, United States
Kaiser Permanente
San Diego, California, 92154, United States
UCSF
San Francisco, California, 94143, United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307, United States
Bach and Godofsky Infectious Diseases
Bradenton, Florida, 34209, United States
University of Florida - Gainesville
Gainesville, Florida, 32610, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
University of Miami School of Medicine
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, 30060, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Private Practice
Opelousas, Louisiana, 70570, United States
Johns Hopkins University
Lutherville, Maryland, 21093, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7584, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
Gastro One
Germantown, Tennessee, 38138, United States
Memphis Gastroenterology Group
Germantown, Tennessee, 38138, United States
Columbia Medical Group, The Frist Clinic
Nashville, Tennessee, 37203, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, 37211, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Research Specialists of Texas
Houston, Texas, 77030, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Lifetree Clinical Research, LC
Salt Lake City, Utah, 84106, United States
Inova Fairfax Hospital - Center for Liver Diseases
Falls Church, Virginia, 22042, United States
Liver Institute of Virginia, Bon Secours Health System
Newport News, Virginia, 23602, United States
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Benedetta Massetto, MD, PhD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2011
First Posted
May 13, 2011
Study Start
May 1, 2011
Primary Completion
October 1, 2012
Study Completion
March 1, 2013
Last Updated
December 20, 2013
Record last verified: 2013-11