A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
NCT ID: NCT01225380
Last Updated: 2014-01-28
Study Results
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Basic Information
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COMPLETED
PHASE2
324 participants
INTERVENTIONAL
2010-10-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
GS-9190 and GS-9256 in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy
GS-9190
GS-9190 capsule, 20 mg BID, 16 or 24 weeks
GS-9256
GS-9256 capsule, 150 mg BID, 16 or 24 weeks
Pegasys®
peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
Arm 2
GS-9256 (active) and placebo matching GS-9190 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy
GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
GS-9256
GS-9256 capsule, 150 mg BID, 24 weeks
Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
Arm 3
Placebo matching GS-9190 and placebo matching GS-9256 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration
GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
GS-9256 placebo
placebo matching GS-9256 capsule BID, 24 weeks
Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), 48 weeks
Interventions
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GS-9190
GS-9190 capsule, 20 mg BID, 16 or 24 weeks
GS-9256
GS-9256 capsule, 150 mg BID, 16 or 24 weeks
Pegasys®
peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
GS-9256
GS-9256 capsule, 150 mg BID, 24 weeks
Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
GS-9190 placebo
placebo matching GS-9190 capsule BID, 24 weeks
GS-9256 placebo
placebo matching GS-9256 capsule BID, 24 weeks
Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
Copegus®
ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), 48 weeks
Eligibility Criteria
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Inclusion Criteria
* 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-naïve
* 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 for ALT, AST, leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium
Exclusion Criteria
* 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 who are on or are expected to be on a potent cytochrome P450 (CYP) 3A4 or Pgp inhibitor, or a QT prolonging medication within 2 weeks of Baseline (Day 1) or during the study
* 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
18 Years
70 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
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Mayo Clinic
Phoenix, Arizona, United States
Advanced Clinical Research Institute
Anaheim, California, United States
Scripps Clinic
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Medical Associates Research Group
San Diego, California, United States
Kaiser Permanente
San Diego, California, United States
California Pacific Medical Center
San Francisco, California, United States
South Denver Gastroenterology
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
University of Miami Center for Liver Diseases
Miami, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Bach and Godofsky Infectious Diseases
Sarasota, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Emory University, Infectious Disease Clinic
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States
Johns Hopkins University
Lutherville, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
North Shore University Hospital
Great Neck, New York, United States
Concorde Medical Group
New York, New York, United States
Cornell University Gastroenterology & Hepatology
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
University Gastroenterology
Providence, Rhode Island, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
The North Texas Research Institute
Arlington, Texas, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Liver Institute of Virginia, Bon Secours
Newport News, Virginia, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Virginia Mason Medical Center, Digestive Disease Institute
Seattle, Washington, United States
Medizinische Universität Graz
Graz, , Austria
LKH Innsbruck
Innsbruck, , Austria
Krankenhaus der Elisabethinen Linz GmbH
Linz, , Austria
AKH der Stadt Wien
Vienna, , Austria
Wilhelminenspital der Stadt Wien
Vienna, , Austria
SGS - Clinical Pharmacology Unit Antwerpen
Antwerp, , Belgium
ULB Erasme
Brussels, , Belgium
UCL Saint Luc
Brussels, , Belgium
UZ Antwerp
Edegem, , Belgium
CHU Sart Tilman
Liège, , Belgium
Heritage Medical Research Clinic
Calgary, Alberta, Canada
University of Alberta, Division of Gastroenterology
Edmonton, Alberta, Canada
Downtown ID Clinic
Vancouver, British Columbia, Canada
Gordon & Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
GI Research Institute
Vancouver, British Columbia, Canada
John Buhler Research Centre
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Ottawa Hospital, Division of Infectious Diseases
Ottawa, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
University Hospital Brno
Brno, , Czechia
Melnik Hospital
Mělník, , Czechia
University Hospital Plzen
Pilsen, , Czechia
Klinmed, s.r.o.
Prague, , Czechia
Institute of Clinic and Experimental Medicine
Prague, , Czechia
Association of Physicians for Infection Diseases
Ústí nad Labem, , Czechia
Beaujon Hospital
Clichy, , France
Henri Mondor Hospital
Créteil, , France
Claude Huriez Hospital
Lille, , France
Hotel Dieu Hospital
Lyon, , France
Saint Joseph Hospital
Marseille, , France
Nancy University Hospital Center
Vandœuvre-lès-Nancy, , France
Charite University Medicine
Berlin, , Germany
University Hospital Bonn
Bonn, , Germany
University Hospital Essen
Essen, , Germany
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt/M, , Germany
University Hospital Freiburg
Freiburg im Breisgau, , Germany
Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
University hospital Heidelberg
Heidelberg, , Germany
University Hospital Leipzig
Leipzig, , Germany
Johannes Gutenberg University Hospital
Mainz, , Germany
Ludwig-Maximilians-University Munich
München, , Germany
Epatologia, Azienda Ospedaliero "Spedali Civili"
Brescia, , Italy
U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Medicina Generale - Azienda Ospedaliera di Padova
Padua, , Italy
U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone
Palermo, , Italy
Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria
Parma, , Italy
Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista
Torino, , Italy
Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny
Bialystok, , Poland
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny
Bydgoszcz, , Poland
Szpital Specjalistyczny w Chorzowie
Chorzów, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia
Czeladź, , Poland
Wojewodzki Szpital Zespolony w Kielcach
Kielce, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, , Poland
Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby
Radom, , Poland
Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie
Szczecin, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny
Warsaw, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X
Warsaw, , Poland
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warsaw, , Poland
EMC Instytut Medyczny S.A.
Wroclaw, , Poland
Hospital Universitari Vall d'Hebrón
Barcelona, , Spain
Hospital Clínico Universitario San Cecilio
Granada, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Puerta de Hierro Majadahonda
Madrid, , Spain
Hospital Universitario Ntra. Sra. de Valme
Seville, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Queen Elizabeth Hospital
Birmingham, , United Kingdom
North Manchester General Hospital
Greater Manchester, , United Kingdom
Royal Liverpool University Hospital
Liverpool, , United Kingdom
Barts and The London Hospital
London, , United Kingdom
University College London Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Chelsea and Westminster Hospital
London, , United Kingdom
Institute of Cellular Medicine (Hepatology)
Newcastle upon Tyne, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Countries
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Other Identifiers
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GS-US-196-0123
Identifier Type: -
Identifier Source: org_study_id
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