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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

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Tegobuvir (GS-9190) (Drug); GS-9451 (Drug); Pegasys® (Biological); Copegus® (Drug); GS-9451 (Drug); Tegobuvir placebo (Drug); Pegasys® (Biological); Copegus® (Drug); Tegobuvir placebo (Drug); GS-9451 placebo (Drug); Pegasys® (Biological); Copegus® (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Bittoo Kanwar, Study Director, Affiliation: Gilead Sciences

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).

Clinical Details

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 Nave Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS US 196 0140

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Sustained virologic response

Secondary outcome:

Safety and tolerability of therapy

Emergence of viral resistance following initiation of therapy with GS 9190 and GS 9451

Viral dynamics and steady state pharmacokinetics

Durability of response in subjects who achieve SVR

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Landeskrankenhaus Graz West, Graz 8020, Austria

Medizinische Universität Graz, Graz 8036, Austria

LKH Innsbruck, Innsbruck 6020, Austria

Krankenhaus der Elisabethinen Linz GmbH, Linz 4020, Austria

AKH der Stadt Wien, Vienna 1090, Austria

Wilhelminenspital der Stadt Wien, Vienna 1171, Austria

Ziekenhuis Netwerk Antwerpen, Antwerpen 2060, Belgium

UCL Saint Luc, Brussels 1200, Belgium

ULB Erasme, Brussels 1070, Belgium

UZ Antwerp, Edegem 2650, Belgium

Centre Hospitalier Universitaire Sart Tilman Liège, Liège, Belgium

Beaujon Hospital, Clichy 92110, France

Henri Mondor Hospital, Créteil 94010, France

Hôpital de la Croix Rousse, Lyon 69004, France

Saint Joseph Hospital, Marseille 13285, France

Hôpital de I´Archet 2, Service Hépatologie, Nice 06200, France

Centre Hospitalier Régional d'Orléans, Hôpital de la Source, Orléans 45067, France

Hôpital Cochin, Paris 75679, France

Groupe Hospitalier du Haut Leveque, Pessac 33604, France

Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil, Strasbourg 67091, France

Nancy University Hospital Center, Vandoeuvre 54511, France

Charite University Medicine, Berlin 13353, Germany

Leber- und Studienzentrum am Checkpoint, Berlin 13353, Germany

University Hospital Bonn, Bonn 53105, Germany

University Hospital Essen, Essen 45122, Germany

Klinikum der Johann Wolfgang Goethe-Universität, Frankfurt/M 60590, Germany

University Hospital Freiburg, Freiburg 79106, Germany

Asklepios Klinik Sankt Georg, Hamburg 20099, Germany

Medizinische Hochschule Hannover, Hannover 30625, Germany

University hospital Heidelberg, Heidelberg 69120, Germany

University Hospital Leipzig, Leipzig 04103, Germany

Johannes Gutenberg University Hospital, Mainz 55131, Germany

Academisch Medisch Centrum Universiteit Van Amsterdam, Amsterdam 1105 AZ, Netherlands

Radaboud University Nijmegen Medical Centre (UMC St Radboud), Nijmegen 6525 GA, Netherlands

Erasmus University Medical Center Rotterdam, Rotterdam 3015 GD, Netherlands

Universitair Medisch Centrum Utrecht, Utrecht 3584 CX, Netherlands

Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny, Bialystok 15-540, Poland

Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny, Bydgoszcz 85-030, Poland

Szpital Specjalistyczny w Chorzowie, Chorzow 41-500, Poland

Niepubliczny Zakład Opieki Zdrowotnej "Pol-SaNa-Med" Sp. z o.o., Czeladź 41-250, Poland

Wojewodzki Szpital Zespolony w Kielcach, Kielce 25-317, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow 31-531, Poland

Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi, Lodz 91-347, Poland

Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie, Lublin 20-081, Poland

Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby, Radom 26-610, Poland

Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Warszawa 02-507, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny, Warszawa 01-201, Poland

Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego, Wrocław 51-149, Poland

Queen Elizabeth Hospital, Birmingham B15 2TH, United Kingdom

Royal Liverpool University Hospital, Liverpool L7 8XP UK, United Kingdom

Barts and The London Hospital, London E1 2AT, United Kingdom

Chelsea and Westminster Hospital, London SW10 9NH, United Kingdom

Kings College Hospital, London SE5 9RS, United Kingdom

Royal Free Hospital, London NW1 2BU, United Kingdom

Saint Mary's Hosptial, London W2 1NY, United Kingdom

Manchester Royal Infirmary, Manchester M13 9WL, United Kingdom

North Manchester General Hospital, Manchester M8 5RB, United Kingdom

Nottingham University Hospitals NHS Trust, Nottingham NG7 2UH, United Kingdom

Derriford Hospital, Plymouth PL6 8DH, United Kingdom

Digestive Health Specialists of the Southeast, Dothan, Alabama 36305, United States

Alabama Liver and Digestive Specialists, Montgomery, Alabama 36116, United States

Mayo Clinic, Phoenix, Arizona 85054, United States

University of Arizona, Tucson, Arizona 85724, United States

Pacific Oaks Medical Group, Beverly Hills, California 90211, United States

eStudySite, Chula Vista, California 91911, United States

Scripps Clinic, La Jolla, California 92037, United States

eStudySite, La Mesa, California 91942, United States

Cedars-Sinai Medical Center, Los Angeles, California 90048, United States

Synergy Clinical Research Center, National City, California 91950, United States

eStudySite, Oceanside, California 92056, United States

Kaiser Permanente, San Diego, California 92154, United States

Medical Associates Research Group, San Diego, California 92123, United States

RESEARCH and EDUCATION, INC, San Diego, California 92015, United States

California Pacific Medical Center, San Francisco, California 94115, United States

San Francisco Veterans Affairs Medical Center, San Francisco, California 94121, United States

University of Colorado Denver, Aurora, Colorado 80045, United States

South Denver Gastroenterology, Englewood, Colorado 80110, United States

Washington Hospital Center, Washington, District of Columbia 20010, United States

Bach and Godofsky Infectious Diseases, Bradenton, Florida 34209, United States

Avail Clinical Research, LLC, Deland, Florida 32720, United States

University of Florida, Gainesville, Florida 32610, United States

Palmetto Research, Hialeah, Florida 33016, United States

University of Miami, Miami, Florida 33136, United States

Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research, North Miami, Florida 33161, United States

Florida Hospital, Orlando, Florida 32804, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

South Florida Center of Gastroenterology, LLC, Wellington, Florida 33414, United States

Atlanta Gastroenterology Associates, Atlanta, Georgia 30308, United States

Emory University, Infectious Disease Clinic, Atlanta, Georgia 30308, United States

Liver Center of Atlanta, Atlanta, Georgia 30309, United States

Dekalb Gastroenterology, Decatur, Georgia 30033, United States

Infectious Disease Specialists of Atlanta, Decatur, Georgia 30033, United States

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States

University of Chicago, Chicago, Illinois 60637, United States

IGRF, Indianapolis, Indiana 46237, United States

Indiana University, Indianapolis, Indiana 46202, United States

Graves Gilbert Clinic, Bowling Green, Kentucky 42101, United States

University of Louisville, Louisville, Kentucky 40202, United States

Gastroenterology Associates, LLC, Baton Rouge, Louisiana 70809, United States

Digestive Disease Associates, PA, Baltimore, Maryland 21229, United States

Johns Hopkins University, Baltimore, Maryland 21287, United States

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Partners in Internal Medicine, P.C., Worcester, Massachusetts 01608, United States

Henry Ford Health System-Columbus center, Novi, Michigan 48377, United States

MN Gastroenterology, P.A., Plymouth, Minnesota 55446, United States

Gastrointestinal Associates, PA, Jackson, Mississippi 39202, United States

Digestive Health Specialists, PA, Tupelo, Mississippi 38801, United States

Saint Louis University, St. Louis, Missouri 63104, United States

Comprehensive Clinical Research, Berlin, New Jersey 08009, United States

ID Care 105, Hillsborough, New Jersey 08844, United States

Atlantic Research Affiliates, LLC, Morristown, New Jersey 07960, United States

University of Medicine and Dentistry of New Jersey, Newark, New Jersey 07103, United States

UNM Health Sciences Center, Albuquerque, New Mexico 87106, United States

Binghamton Gastroenterology, Binghamton, New York 13903, United States

North Shore University Hospital, Manhasset, New York 11030, United States

Columbia University Medical Center, New York, New York 10032, United States

Concorde Medical Group, New York, New York 10016, United States

Cornell University Gastroenterology & Hepatology, New York, New York 10021, United States

Mount Sinai Medical Center, New York, New York 10029, United States

NYU Hepatology Associates, New York, New York 10016, United States

Asheville Gastroenterology Associates, P.A., Asheville, North Carolina 28801, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Consultants for Clinical, Cincinnati, Ohio 45219, United States

University of Cincinnati, Cincinnati, Ohio 45267, United States

University Hospitals Case Medical Center, Cleveland, Ohio 44106, United States

Options Health Research, LLC, Tulsa, Oklahoma 74104, United States

Albert Einstein Medical Center, Philadelphia, Pennsylvania 19141, United States

Memphis Gastroenterology Group, Germantown, Tennessee 38138, United States

James H. Quillen VA Medical Center, Mountain Home, Tennessee 37684, United States

Columbia Medical Group, The Frist Clinic, Nashville, Tennessee 37203, United States

The North Texas Research Institute, Arlington, Texas 76012, United States

UT Southwestern Medical Center at Dallas, Dallas, Texas 75390-8887, United States

Advanced Liver Therapies, Houston, Texas 77030, United States

Amcare Research Inc., Houston, Texas 77090, United States

Kelsey Research Foundation, Houston, Texas 77005, United States

Research Specialists of Texas, Houston, Texas 77030, United States

Alamo Medical Research, San Antonio, Texas 78215, United States

Brooke Army Medical Center, San Antonio, Texas 78234, United States

Metropolitan Research, Fairfax, Virginia 22031, United States

Liver Institute of Virginia, Bon Secours, Newport News, Virginia 23602, United States

Digestive and Liver Disease Specialists, Norfolk, Virginia 23502, United States

Virginia Mason Medical Center, Digestive Disease Institute, Seattle, Washington 98101, United States

University of Wisconsin Hospital & Clinics, Madison, Wisconsin 53792, United States

Additional Information

Starting date: October 2010
Last updated: January 8, 2014

Page last updated: August 23, 2015

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