Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy Using Combinations of Oral Antivirals (GS-5885, Tegobuvir, and/or GS-9451) With Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol GS US 256 0124)
1 other identifier
interventional
163
2 countries
55
Brief Summary
This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy using Combinations of Oral Antivirals (GS-5885, tegobuvir, and/or GS-9451) with Peginterferon Alfa 2a and Ribavirin in Treatment Experienced Subjects with Chronic Genotype 1 Hepatitis C Virus (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 Jul 2011
55 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
June 9, 2011
CompletedFirst Posted
Study publicly available on registry
June 13, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFebruary 11, 2014
January 1, 2014
1.7 years
June 9, 2011
January 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sustained Virologic Response (SVR)
To evaluate antiviral efficacy as measured by sustained virologic response (SVR, defined as HCV RNA \< Lower Limit of Quantification (LLoQ) 24 weeks post-treatment) of response guided therapy (RGT) with GS-9451 + GS-5885, with peginterferon alfa-2a (PEG) and ribavirin (RBV) in treatment-experienced subjects.
through 24 weeks of off-treatment follow-up
Secondary Outcomes (5)
Sustained Virologic Response(SVR) of each regimen administered for 24 to 48 weeks
Weeks 1, 2, 4, 8, 12, 16, 20, 24, 36, 48 and at 4 and 12 weeks off-treatment
Safety and Tolerability
through 24 to 48 week treatment period and up to 24 weeks of off-treatment follow-up
Characterize the viral dynamics of GS-5885, GS-9451 when administered in combination with PEG and RBV
Through Week 2 of therapy
Characterize the pharmacokinetics of GS-5885 and GS-9451 when administered in combination with PEG and RBV
Through Week 2 of therapy
Emergence of Viral Resistance
through 24 to 48 week treatment period and up to 24 weeks of off-treatment follow-up
Study Arms (1)
Arm 2
EXPERIMENTALAM Dosing: One GS-5885 30 mg tablet, two GS-9451 100 mg tablets, orally with RBV and with food. PM Dosing: RBV with food. PEG, 180 µg, will be administered weekly by subcutaneous injection for the specified period of time (see Study Design). Pegasys® prefilled syringes (Hoffman-La Roche) will be supplied by Gilead Sciences.
Interventions
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
Eligibility Criteria
You may qualify if:
- Male or female, aged from 18 to 70 years old, inclusive
- Chronic HCV infection for at least 6 months prior to Baseline
- Subjects must have liver biopsy results (≤ 3 years prior to screening) indicating the absence of cirrhosis.
- Monoinfection with HCV genotype 1
- HCV RNA \> 10\^4 IU/mL at Screening
- Prior treatment and adherence (as defined by receiving at least 80% of the prescribed treatment) with one course of a pegylated interferon-alfa (Pegasys or Peg-Intron) and RBV
- The subject's medical records must include sufficient detail of prior treatment with pegylated interferon-alfa and RBV (start/stop dates and viral response) to allow for categorization of prior response as either
- Non-Responder: Subject did not achieve undetectable HCV RNA levels during or at the end of a treatment period of at least 12 weeks duration. Within Nonresponders, subjects will be further defined as Null or Partial Responders if they had \< 2 log10 or ≥ 2 log10 reduction, respectively, in HCV RNA during the first 12 weeks of treatment
- Responder: Subject achieved undetectable HCV RNA during treatment. Within Responders, subjects will be further defined as Relapsers if they had undetectable HCV RNA at the end of at least 42 weeks of treatment but detectable HCV RNA levels observed within 1 year of the end of treatment and Breakthrough subjects if they achieved undetectable HCV RNA levels during the treatment period but detectable HCV RNA at the end of treatment.
- No prior treatment with an oral HCV antiviral (exclusive of RBV).
- Body mass index (BMI) 18-36 kg/m2, inclusive.
- Screening ECG without clinically significant abnormalities and with QTcF interval (QT corrected using Fridericia's formula) ≤ 450 msec for males and ≤ 470 msec for females
- Creatinine clearance ≥ 50 mL/min.
- Agree to use two forms of highly effective contraception for the duration of the study and for 6 months after the last dose of study medication. Females of childbearing potential must have a negative pregnancy test at Screening and Baseline
You may not qualify if:
- Discontinued prior treatment with pegylated interferon-alfa and RBV due to an adverse event, toxicity reasons or were lost to follow-up.
- 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), or another HCV genotype, hepatocellular carcinoma or other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
- Receiving any of the prohibited concomitant medications.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (55)
Digestive Health Specialists of the Southeast
Dothan, Alabama, 36305, United States
Alabama Liver and Digestive Specialists
Montgomery, Alabama, 36116, United States
California Liver Institute
Beverly Hills, California, 90211, United States
Scripps Clinic
La Jolla, California, 92037, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
RESEARCH and EDUCATION, INC
San Diego, California, 92015, United States
Medical Associates Research Group
San Diego, California, 92123, United States
Kaiser Permanente
San Diego, California, 92154, United States
University of Colorado Denver
Aurora, Colorado, 80045, United States
South Denver Gastroenterology
Englewood, Colorado, 80110, United States
Bach and Godofsky Infectious Diseases
Bradenton, Florida, 34209, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
South Florida Center of Gastroenterology, LLC
Wellington, Florida, 33414, United States
Emory University, Infectious Disease Clinic
Atlanta, Georgia, 30308, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Dekalb Gastroenterology
Decatur, Georgia, 30033, United States
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, 30060, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, 42101, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Digestive Disease Associates, PA
Baltimore, Maryland, 21229, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
Partners in Internal Medicine, P.C.
Worcester, Massachusetts, 01608, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, 39202, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, 38801, United States
ID Care 105
Hillsborough, New Jersey, 08844, United States
Atlantic Research Affiliates, LLC
Morristown, New Jersey, 07960, United States
Southwest CARE Center
Santa Fe, New Mexico, 87505, United States
Binghamton Gastroenterology
Binghamton, New York, 13903, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Concorde Medical Group
New York, New York, 10016, United States
Cornell University Gastroenterology & Hepatology
New York, New York, 10021, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, 28304, United States
University of Cincinnati
Cincinnati, Ohio, 45267, United States
Options Health Research, LLC
Tulsa, Oklahoma, 74104, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Memphis Gastroenterology Group
Germantown, Tennessee, 38138, United States
Columbia Medical Group, The Frist Clinic
Nashville, Tennessee, 37203, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, 37211, United States
The North Texas Research Institute
Arlington, Texas, 76012, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
Kelsey Research Foundation
Houston, Texas, 77005, United States
Research Specialists of Texas
Houston, Texas, 77030, United States
Metropolitan Research
Fairfax, Virginia, 22031, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Liver Institute of Virginia
Richmond, Virginia, 23249, United States
Virginia Mason Medical Center, Digestive Disease Institute
Seattle, Washington, 98101, 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 CHAIR
Bittoo Kanwar, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 9, 2011
First Posted
June 13, 2011
Study Start
July 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
February 11, 2014
Record last verified: 2014-01