Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 11 for:    GS-9451 OR Vedroprevir

A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01271790
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Tegobuvir (GS-9190) Drug: GS-9451 Biological: Pegasys® Drug: Copegus® Drug: Tegobuvir placebo Drug: GS-9451 placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 245 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS US 196 0140
Study Start Date : October 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Arm 1
GS-9451 and Tegobuvir (GS-9190) 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
Drug: Tegobuvir (GS-9190)
Tegobuvir (GS-9190) capsule, 30 mg BID

Drug: GS-9451
GS-9451 tablet, 200 mg once daily (QD)

Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week

Drug: Copegus®
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

Active Comparator: Arm 2
GS-9451 (active) and Tegobuvir (GS-9190) placebo 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
Drug: GS-9451
GS-9451 tablet, 200 mg QD

Drug: Tegobuvir placebo
placebo matching Tegobuvir (GS-9190) capsule BID

Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week

Drug: Copegus®
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)

Placebo Comparator: Arm 3
Placebo matching Tegobuvir (GS-9190) and GS-9451 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration
Drug: Tegobuvir placebo
placebo matching Tegobuvir (GS-9190) capsule BID

Drug: GS-9451 placebo
placebo matching GS-9451 tablet QD

Biological: Pegasys®
peginterferon alfa-2a (solution for injection) 180 µg/week

Drug: Copegus®
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet




Primary Outcome Measures :
  1. Sustained virologic response [ Time Frame: 24 weeks of off-treatment follow-up ]
    Sustained virologic response (SVR) defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after treatment cessation


Secondary Outcome Measures :
  1. Safety and tolerability of therapy [ Time Frame: Through treatment period and 24 weeks of off-treatment follow-up ]
    Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events

  2. Emergence of viral resistance following initiation of therapy with GS 9190 and GS 9451 [ Time Frame: Through treatment period, 24 weeks of off-treatment follow-up, and up to 48 weeks of follow-up in the Resistance Registry Substudy ]
  3. Viral dynamics and steady state pharmacokinetics [ Time Frame: Through Week 4 of therapy ]
    Viral dynamics and steady state pharmacokinetics of GS 9190 and GS 9451 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9451 over time

  4. Durability of response in subjects who achieve SVR [ Time Frame: 36 months following Week 72 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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-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 alanine aminotransferase (ALT), aspartate aminotransferase (AST), leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH), potassium, magnesium

Exclusion Criteria:

  • 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271790


  Hide Study Locations
Locations
Layout table for location information
United States, Alabama
Digestive Health Specialists of the Southeast
Dothan, Alabama, United States, 36305
Alabama Liver and Digestive Specialists
Montgomery, Alabama, United States, 36116
United States, Arizona
Mayo Clinic
Phoenix, Arizona, United States, 85054
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
Pacific Oaks Medical Group
Beverly Hills, California, United States, 90211
eStudySite
Chula Vista, California, United States, 91911
Scripps Clinic
La Jolla, California, United States, 92037
eStudySite
La Mesa, California, United States, 91942
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Synergy Clinical Research Center
National City, California, United States, 91950
eStudySite
Oceanside, California, United States, 92056
RESEARCH and EDUCATION, INC
San Diego, California, United States, 92015
Medical Associates Research Group
San Diego, California, United States, 92123
Kaiser Permanente
San Diego, California, United States, 92154
California Pacific Medical Center
San Francisco, California, United States, 94115
San Francisco Veterans Affairs Medical Center
San Francisco, California, United States, 94121
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
South Denver Gastroenterology
Englewood, Colorado, United States, 80110
United States, District of Columbia
Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Florida
Bach and Godofsky Infectious Diseases
Bradenton, Florida, United States, 34209
Avail Clinical Research, LLC
Deland, Florida, United States, 32720
University of Florida
Gainesville, Florida, United States, 32610
Palmetto Research
Hialeah, Florida, United States, 33016
University of Miami
Miami, Florida, United States, 33136
Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research
North Miami, Florida, United States, 33161
Orlando Immunology Center
Orlando, Florida, United States, 32803
Florida Hospital
Orlando, Florida, United States, 32804
South Florida Center of Gastroenterology, LLC
Wellington, Florida, United States, 33414
United States, Georgia
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States, 30308
Emory University, Infectious Disease Clinic
Atlanta, Georgia, United States, 30308
Liver Center of Atlanta
Atlanta, Georgia, United States, 30309
Dekalb Gastroenterology
Decatur, Georgia, United States, 30033
Infectious Disease Specialists of Atlanta
Decatur, Georgia, United States, 30033
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
IGRF
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Graves Gilbert Clinic
Bowling Green, Kentucky, United States, 42101
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Digestive Disease Associates, PA
Baltimore, Maryland, United States, 21229
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Partners in Internal Medicine, P.C.
Worcester, Massachusetts, United States, 01608
United States, Michigan
Henry Ford Health System-Columbus center
Novi, Michigan, United States, 48377
United States, Minnesota
MN Gastroenterology, P.A.
Plymouth, Minnesota, United States, 55446
United States, Mississippi
Gastrointestinal Associates, PA
Jackson, Mississippi, United States, 39202
Digestive Health Specialists, PA
Tupelo, Mississippi, United States, 38801
United States, Missouri
Saint Louis University
St. Louis, Missouri, United States, 63104
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
ID Care 105
Hillsborough, New Jersey, United States, 08844
Atlantic Research Affiliates, LLC
Morristown, New Jersey, United States, 07960
University of Medicine and Dentistry of New Jersey
Newark, New Jersey, United States, 07103
United States, New Mexico
UNM Health Sciences Center
Albuquerque, New Mexico, United States, 87106
United States, New York
Binghamton Gastroenterology
Binghamton, New York, United States, 13903
North Shore University Hospital
Manhasset, New York, United States, 11030
Concorde Medical Group
New York, New York, United States, 10016
NYU Hepatology Associates
New York, New York, United States, 10016
Cornell University Gastroenterology & Hepatology
New York, New York, United States, 10021
Mount Sinai Medical Center
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, United States, 28801
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Consultants for Clinical
Cincinnati, Ohio, United States, 45219
University of Cincinnati
Cincinnati, Ohio, United States, 45267
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Oklahoma
Options Health Research, LLC
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Albert Einstein Medical Center
Philadelphia, Pennsylvania, United States, 19141
United States, Tennessee
Memphis Gastroenterology Group
Germantown, Tennessee, United States, 38138
James H. Quillen VA Medical Center
Mountain Home, Tennessee, United States, 37684
Columbia Medical Group, The Frist Clinic
Nashville, Tennessee, United States, 37203
United States, Texas
The North Texas Research Institute
Arlington, Texas, United States, 76012
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8887
Kelsey Research Foundation
Houston, Texas, United States, 77005
Advanced Liver Therapies
Houston, Texas, United States, 77030
Research Specialists of Texas
Houston, Texas, United States, 77030
Amcare Research Inc.
Houston, Texas, United States, 77090
Alamo Medical Research
San Antonio, Texas, United States, 78215
Brooke Army Medical Center
San Antonio, Texas, United States, 78234
United States, Virginia
Metropolitan Research
Fairfax, Virginia, United States, 22031
Liver Institute of Virginia, Bon Secours
Newport News, Virginia, United States, 23602
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
United States, Washington
Virginia Mason Medical Center, Digestive Disease Institute
Seattle, Washington, United States, 98101
United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53792
Austria
Landeskrankenhaus Graz West
Graz, Austria, 8020
Medizinische Universität Graz
Graz, Austria, 8036
LKH Innsbruck
Innsbruck, Austria, 6020
Krankenhaus der Elisabethinen Linz GmbH
Linz, Austria, 4020
AKH der Stadt Wien
Vienna, Austria, 1090
Wilhelminenspital der Stadt Wien
Vienna, Austria, 1171
Belgium
Ziekenhuis Netwerk Antwerpen
Antwerpen, Belgium, 2060
ULB Erasme
Brussels, Belgium, 1070
UCL Saint Luc
Brussels, Belgium, 1200
UZ Antwerp
Edegem, Belgium, 2650
Centre Hospitalier Universitaire Sart Tilman Liège
Liège, Belgium
France
Beaujon Hospital
Clichy, France, 92110
Henri Mondor Hospital
Créteil, France, 94010
Hôpital de la Croix Rousse
Lyon, France, 69004
Saint Joseph Hospital
Marseille, France, 13285
Hôpital de I´Archet 2, Service Hépatologie
Nice, France, 06200
Centre Hospitalier Régional d'Orléans, Hôpital de la Source
Orléans, France, 45067
Hôpital Cochin
Paris, France, 75679
Groupe Hospitalier du Haut Leveque
Pessac, France, 33604
Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil
Strasbourg, France, 67091
Nancy University Hospital Center
Vandoeuvre, France, 54511
Germany
Charite University Medicine
Berlin, Germany, 13353
Leber- und Studienzentrum am Checkpoint
Berlin, Germany, 13353
University Hospital Bonn
Bonn, Germany, 53105
University Hospital Essen
Essen, Germany, 45122
Klinikum der Johann Wolfgang Goethe-Universität
Frankfurt/M, Germany, 60590
University Hospital Freiburg
Freiburg, Germany, 79106
Asklepios Klinik Sankt Georg
Hamburg, Germany, 20099
Medizinische Hochschule Hannover
Hannover, Germany, 30625
University hospital Heidelberg
Heidelberg, Germany, 69120
University Hospital Leipzig
Leipzig, Germany, 04103
Johannes Gutenberg University Hospital
Mainz, Germany, 55131
Netherlands
Academisch Medisch Centrum Universiteit Van Amsterdam
Amsterdam, Netherlands, 1105 AZ
Radaboud University Nijmegen Medical Centre (UMC St Radboud)
Nijmegen, Netherlands, 6525 GA
Erasmus University Medical Center Rotterdam
Rotterdam, Netherlands, 3015 GD
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584 CX
Poland
Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny
Bialystok, Poland, 15-540
Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny
Bydgoszcz, Poland, 85-030
Szpital Specjalistyczny w Chorzowie
Chorzow, Poland, 41-500
Niepubliczny Zakład Opieki Zdrowotnej "Pol-SaNa-Med" Sp. z o.o.
Czeladź, Poland, 41-250
Wojewodzki Szpital Zespolony w Kielcach
Kielce, Poland, 25-317
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow, Poland, 31-531
Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi
Lodz, Poland, 91-347
Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
Lublin, Poland, 20-081
Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby
Radom, Poland, 26-610
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny
Warszawa, Poland, 01-201
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
Warszawa, Poland, 02-507
Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego
Wrocław, Poland, 51-149
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom, B15 2TH
Royal Liverpool University Hospital
Liverpool, United Kingdom, L7 8XP UK
Barts and The London Hospital
London, United Kingdom, E1 2AT
Royal Free Hospital
London, United Kingdom, NW1 2BU
Kings College Hospital
London, United Kingdom, SE5 9RS
Chelsea and Westminster Hospital
London, United Kingdom, SW10 9NH
Saint Mary's Hosptial
London, United Kingdom, W2 1NY
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
North Manchester General Hospital
Manchester, United Kingdom, M8 5RB
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG7 2UH
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Sponsors and Collaborators
Gilead Sciences
Investigators
Layout table for investigator information
Study Director: Bittoo Kanwar Gilead Sciences

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01271790     History of Changes
Other Study ID Numbers: GS-US-196-0140
First Posted: January 7, 2011    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: January 2014

Keywords provided by Gilead Sciences:
GS-9451
Hepatitis C
HCV
Rapid Virologic Response
Sustained Virologic Response
Direct Acting Antiviral
Combination Therapy
HCV RNA
Polymerase inhibitor
Protease inhibitor
Treatment naïve
GS-9190

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs