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
NCT ID: NCT01371578
Last Updated: 2014-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
163 participants
INTERVENTIONAL
2011-07-31
2013-03-31
Brief Summary
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Detailed Description
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In 2 HCV-infected people that were given tegobuvir with another experimental medication plus interferon and ribavirin, big reductions in the number of white blood cells, red blood cells and platelets were seen. Because these cases might have been related to tegobuvir when given with interferon, ribavirin and another direct antiviral agent, tegobuvir is no longer being given to people with these other medications in this study.
As a result, the study is now open label which means both you and your study doctor will know the medication you will be receiving and Arms 1 and 3 have been discontinued from the study.
All subjects enrolled in the study as of September 2nd 2011 will receive Response Guided Therapy (RGT) with both GS-5885 and GS-9451 plus PEG and RBV.
Conditions
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Study Design
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PARALLEL
TREATMENT
NONE
Study Groups
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Arm 2
AM 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.
GS-5885 tablet
30 mg active tablet
GS-9451 tablet
two active 100 mg tablets
peginterferon alfa-2a
peginterferon alfa-2a (solution for injection) 180 µg/week
ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
Interventions
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GS-5885 tablet
30 mg active tablet
GS-9451 tablet
two active 100 mg tablets
peginterferon alfa-2a
peginterferon alfa-2a (solution for injection) 180 µg/week
ribavirin tablet
ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* Current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Subjects on stable methadone are excluded, however stable buprenorphine maintenance treatment for at least 6 months is not exclusionary
* Receiving any of the prohibited concomitant medications.
18 Years
80 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Bittoo Kanwar, MD
Role: STUDY_CHAIR
Gilead Sciences
Locations
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Digestive Health Specialists of the Southeast
Dothan, Alabama, United States
Alabama Liver and Digestive Specialists
Montgomery, Alabama, United States
California Liver Institute
Beverly Hills, California, United States
Scripps Clinic
La Jolla, California, United States
University of California Davis Medical Center
Sacramento, California, United States
RESEARCH and EDUCATION, INC
San Diego, California, United States
Medical Associates Research Group
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
University of Colorado Denver
Aurora, Colorado, United States
South Denver Gastroenterology
Englewood, Colorado, United States
Bach and Godofsky Infectious Diseases
Bradenton, Florida, United States
University of Florida
Gainesville, Florida, United States
University of Miami
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
South Florida Center of Gastroenterology, LLC
Wellington, Florida, United States
Emory University, Infectious Disease Clinic
Atlanta, Georgia, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, United States
Dekalb Gastroenterology
Decatur, Georgia, United States
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Graves Gilbert Clinic
Bowling Green, Kentucky, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Digestive Disease Associates, PA
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Partners in Internal Medicine, P.C.
Worcester, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, United States
Digestive Health Specialists, PA
Tupelo, Mississippi, United States
ID Care 105
Hillsborough, New Jersey, United States
Atlantic Research Affiliates, LLC
Morristown, New Jersey, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
Binghamton Gastroenterology
Binghamton, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Concorde Medical Group
New York, New York, United States
Cornell University Gastroenterology & Hepatology
New York, New York, United States
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cumberland Research Associates, LLC
Fayetteville, North Carolina, United States
University of Cincinnati
Cincinnati, Ohio, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
University Gastroenterology
Providence, Rhode Island, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Columbia Medical Group, The Frist Clinic
Nashville, Tennessee, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, United States
The North Texas Research Institute
Arlington, Texas, United States
Baylor University Medical Center
Dallas, Texas, United States
Kelsey Research Foundation
Houston, Texas, United States
Research Specialists of Texas
Houston, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Liver Institute of Virginia
Richmond, Virginia, United States
Virginia Mason Medical Center, Digestive Disease Institute
Seattle, Washington, United States
Fundacion de Investigacion de Diego
San Juan, , Puerto Rico
Countries
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Other Identifiers
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GS-US-256-0124
Identifier Type: -
Identifier Source: org_study_id
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