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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

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

Condition(s) targeted: Chronic Hepatitis C Infection

Intervention: GS-9190 (Drug); GS-9256 (Drug); Pegasys® (Biological); Copegus® (Drug); GS-9190 placebo (Drug); GS-9256 (Drug); Pegasys® (Biological); Copegus® (Drug); GS-9190 placebo (Drug); GS-9256 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 response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) will be evaluated.

Clinical Details

Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus) and Peginterferon Alfa 2a (Pegasys) in Treatment Nave Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)

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 (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation

Secondary outcome:

Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events

Emergence of viral resistance following initiation of therapy with GS-9190 and GS-9256

Viral dynamics and steady state pharmacokinetics of GS-9190 and GS-9256 when administered in combination with PEG and RBV; measured by HCV RNA levels and plasma concentrations of GS-9190 and GS-9256 over time

Long-term assessment of plasma HCV RNA 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 ALT, 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

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

SGS - Clinical Pharmacology Unit Antwerpen, Antwerpen 2060, Belgium

UCL Saint Luc, Brussels 1200, Belgium

ULB Erasme, Brussels 1070, Belgium

UZ Antwerp, Edegem 2650, Belgium

CHU Sart Tilman, Liege 4000, Belgium

University Hospital Brno, Brno 625 00, Czech Republic

Melnik Hospital, Melnik 276 01, Czech Republic

University Hospital Plzen, Plzen 304 60, Czech Republic

Institute of Clinic and Experimental Medicine, Prague 140 21, Czech Republic

Klinmed, s.r.o., Prague 128 00, Czech Republic

Association of Physicians for Infection Diseases, Usti Nad labem 477 01, Czech Republic

Beaujon Hospital, Clichy 92110, France

Henri Mondor Hospital, Créteil 94000, France

Claude Huriez Hospital, Lille 59000, France

Hotel Dieu Hospital, Lyon 69002, France

Saint Joseph Hospital, Marseille 13008, France

Nancy University Hospital Center, Vandoeuvre 54500, France

Charite University Medicine, 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

Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH, 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

Ludwig-Maximilians-University Munich, München 81377, Germany

Epatologia, Azienda Ospedaliero "Spedali Civili", Brescia 25123, Italy

U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano 20122, Italy

Medicina Generale - Azienda Ospedaliera di Padova, Padova 35128, Italy

U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone, Palermo 90127, Italy

Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria, Parma 43100, Italy

Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista, Torino 10126, Italy

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 Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia, Czeladz 41-250, Poland

Wojewodzki Szpital Zespolony w Kielcach, Kielce 25-736, Poland

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie, Krakow 31-501, 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

Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie, Szczecin 71-455, 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

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X, Warszawa 01-201, Poland

EMC Instytut Medyczny S.A., Wroclaw 50-220, Poland

Hospital Universitari Vall d'Hebrón, Barcelona 08035, Spain

Hospital Clínico Universitario San Cecilio, Granada 18012, Spain

Hospital Universitario Puerta de Hierro Majadahonda, Madrid 28222, Spain

Hospital Universitario Ramón y Cajal, Madrid 28034, Spain

Hospital Universitario Ntra. Sra. de Valme, Sevilla 41014, Spain

Hospital General Universitario de Valencia, Valencia 46014, Spain

Queen Elizabeth Hospital, Birmingham B15 2TH, United Kingdom

North Manchester General Hospital, Greater Manchester M8 5RB, 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 SW109NH, United Kingdom

Kings College Hospital, London SE5 9RS, United Kingdom

University College London Hospital, London NW1 2BU, United Kingdom

Institute of Cellular Medicine (Hepatology), Newcastle Upon Tyne NE24HH, United Kingdom

Derriford Hospital, Plymouth PL6 8DH, United Kingdom

Heritage Medical Research Clinic, Calgary, Alberta T2N 4N1, Canada

University of Alberta, Division of Gastroenterology, Edmonton, Alberta T6G 2C2, Canada

Mayo Clinic, Phoenix, Arizona 85054, United States

Downtown ID Clinic, Vancouver, British Columbia V3S 4N9, Canada

GI Research Institute, Vancouver, British Columbia V6Z 2K5, Canada

Gordon & Leslie Diamond Health Care Centre, Vancouver, British Columbia V5Z 3P1, Canada

Advanced Clinical Research Institute, Anaheim, California 92801, United States

Scripps Clinic, La Jolla, California 92037, United States

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

Kaiser Permanente, San Diego, California 92154, United States

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

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

South Denver Gastroenterology, Englewood, Colorado 80110, United States

University of Florida, Gainesville, Florida 32610, United States

University of Miami Center for Liver Diseases, Miami, Florida 33136, United States

Orlando Immunology Center, Orlando, Florida 32803, United States

Bach and Godofsky Infectious Diseases, Sarasota, Florida 34243, United States

Atlanta Gastroenterology Associates, Atlanta, Georgia 30308, United States

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

Northwestern Memorial Hospital, Chicago, Illinois 60611, United States

Indiana University, Indianapolis, Indiana 46202, United States

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

John Buhler Research Centre, Winnipeg, Manitoba R3E 3P4, Canada

Johns Hopkins University, Lutherville, Maryland 21093, United States

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

Henry Ford Health System, Detroit, Michigan 48202, United States

Southwest CARE Center, Santa Fe, New Mexico 87505, United States

North Shore University Hospital, Great Neck, New York 11021, 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

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

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

London Health Sciences Centre, London, Ontario N6A 5A5, Canada

Ottawa Hospital, Division of Infectious Diseases, Ottawa, Ontario K1H 8L6, Canada

Toronto General Hospital, Toronto, Ontario M5G 2C4, Canada

Toronto Western Hospital, Toronto, Ontario M5T 2S8, Canada

University Gastroenterology, Providence, Rhode Island 02905, United States

Memphis Gastroenterology Group, Germantown, Tennessee 38138, United States

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

UT Southwestern Medical Center at Dallas, Dallas, Texas 39090, United States

Alamo Medical Research, San Antonio, Texas 78215, 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

Additional Information

Starting date: October 2010
Last updated: December 20, 2013

Page last updated: August 23, 2015

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