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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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tegobuvir (GS-9190)
GS-9451
Pegasys®
Copegus®
GS-9451
Tegobuvir placebo
Pegasys®
Copegus®
Tegobuvir placebo
GS-9451 placebo
Pegasys®
Copegus®
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, HCV RNA, Polymerase inhibitor, Protease inhibitor, Treatment naïve, GS-9190, GS-9451

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Digestive Health Specialists of the Southeast
  • Alabama Liver and Digestive Specialists
  • Mayo Clinic
  • University of Arizona
  • Pacific Oaks Medical Group
  • eStudySite
  • Scripps Clinic
  • eStudySite
  • Cedars-Sinai Medical Center
  • Synergy Clinical Research Center
  • eStudySite
  • RESEARCH and EDUCATION, INC
  • Medical Associates Research Group
  • Kaiser Permanente
  • California Pacific Medical Center
  • San Francisco Veterans Affairs Medical Center
  • University of Colorado Denver
  • South Denver Gastroenterology
  • Washington Hospital Center
  • Bach and Godofsky Infectious Diseases
  • Avail Clinical Research, LLC
  • University of Florida
  • Palmetto Research
  • University of Miami
  • Scientific Clinical Research, Inc c/o Segal Institute for Clinical Research
  • Orlando Immunology Center
  • Florida Hospital
  • South Florida Center of Gastroenterology, LLC
  • Atlanta Gastroenterology Associates
  • Emory University, Infectious Disease Clinic
  • Liver Center of Atlanta
  • Dekalb Gastroenterology
  • Infectious Disease Specialists of Atlanta
  • Northwestern Memorial Hospital
  • University of Chicago
  • Indiana University
  • IGRF
  • Graves Gilbert Clinic
  • University of Louisville
  • Gastroenterology Associates, LLC
  • Digestive Disease Associates, PA
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Partners in Internal Medicine, P.C.
  • Henry Ford Health System-Columbus center
  • MN Gastroenterology, P.A.
  • Gastrointestinal Associates, PA
  • Digestive Health Specialists, PA
  • Saint Louis University
  • Comprehensive Clinical Research
  • ID Care 105
  • Atlantic Research Affiliates, LLC
  • University of Medicine and Dentistry of New Jersey
  • UNM Health Sciences Center
  • Binghamton Gastroenterology
  • North Shore University Hospital
  • Concorde Medical Group
  • NYU Hepatology Associates
  • Cornell University Gastroenterology & Hepatology
  • Mount Sinai Medical Center
  • Columbia University Medical Center
  • Asheville Gastroenterology Associates, P.A.
  • Duke University Medical Center
  • Consultants for Clinical
  • University of Cincinnati
  • University Hospitals Case Medical Center
  • Options Health Research, LLC
  • Albert Einstein Medical Center
  • Memphis Gastroenterology Group
  • James H. Quillen VA Medical Center
  • Columbia Medical Group, The Frist Clinic
  • The North Texas Research Institute
  • UT Southwestern Medical Center at Dallas
  • Kelsey Research Foundation
  • Advanced Liver Therapies
  • Research Specialists of Texas
  • Amcare Research Inc.
  • Alamo Medical Research
  • Brooke Army Medical Center
  • Metropolitan Research
  • Liver Institute of Virginia, Bon Secours
  • Digestive and Liver Disease Specialists
  • Virginia Mason Medical Center, Digestive Disease Institute
  • University of Wisconsin Hospital & Clinics
  • Landeskrankenhaus Graz West
  • Medizinische Universität Graz
  • LKH Innsbruck
  • Krankenhaus der Elisabethinen Linz GmbH
  • AKH der Stadt Wien
  • Wilhelminenspital der Stadt Wien
  • Ziekenhuis Netwerk Antwerpen
  • ULB Erasme
  • UCL Saint Luc
  • UZ Antwerp
  • Centre Hospitalier Universitaire Sart Tilman Liège
  • Beaujon Hospital
  • Henri Mondor Hospital
  • Hôpital de la Croix Rousse
  • Saint Joseph Hospital
  • Hôpital de I´Archet 2, Service Hépatologie
  • Centre Hospitalier Régional d'Orléans, Hôpital de la Source
  • Hôpital Cochin
  • Groupe Hospitalier du Haut Leveque
  • Centre Hospitalier Universitaire de Strasbourg - Hôpital Civil
  • Nancy University Hospital Center
  • Charite University Medicine
  • Leber- und Studienzentrum am Checkpoint
  • University Hospital Bonn
  • University Hospital Essen
  • Klinikum der Johann Wolfgang Goethe-Universität
  • University Hospital Freiburg
  • Asklepios Klinik Sankt Georg
  • Medizinische Hochschule Hannover
  • University hospital Heidelberg
  • University Hospital Leipzig
  • Johannes Gutenberg University Hospital
  • Academisch Medisch Centrum Universiteit Van Amsterdam
  • Radaboud University Nijmegen Medical Centre (UMC St Radboud)
  • Erasmus University Medical Center Rotterdam
  • Universitair Medisch Centrum Utrecht
  • Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny
  • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny
  • Szpital Specjalistyczny w Chorzowie
  • Niepubliczny Zakład Opieki Zdrowotnej "Pol-SaNa-Med" Sp. z o.o.
  • Wojewodzki Szpital Zespolony w Kielcach
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
  • Wojewodzki Specjalistyczny Szpital im. Dr Wl. Bieganskiego w Lodzi
  • Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie
  • Radomski Szpital Specjalistyczny im. Dr Tytusa Chalubinskiego Oddzial obserwacyjno-zakazny z odcinkiem jednego dnia leczenia chorob watroby
  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
  • Wojewódzki Szpital Specjalistyczny im. J. Gromkowskiego
  • Queen Elizabeth Hospital
  • Royal Liverpool University Hospital
  • Barts and The London Hospital
  • Royal Free Hospital
  • Kings College Hospital
  • Chelsea and Westminster Hospital
  • Saint Mary's Hosptial
  • Manchester Royal Infirmary
  • North Manchester General Hospital
  • Nottingham University Hospitals NHS Trust
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Arm 1

Arm 2

Arm 3

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Sustained virologic response
Sustained virologic response (SVR) defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after treatment cessation

Secondary Outcome Measures

Safety and tolerability of therapy
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 9451
Viral dynamics and steady state pharmacokinetics
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
Durability of response in subjects who achieve SVR

Full Information

First Posted
January 5, 2011
Last Updated
January 8, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01271790
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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®).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, HCV, Rapid Virologic Response, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, HCV RNA, Polymerase inhibitor, Protease inhibitor, Treatment naïve, GS-9190, GS-9451

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
245 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm 2
Arm Type
Active Comparator
Arm Description
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
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Tegobuvir (GS-9190)
Intervention Description
Tegobuvir (GS-9190) capsule, 30 mg BID
Intervention Type
Drug
Intervention Name(s)
GS-9451
Intervention Description
GS-9451 tablet, 200 mg once daily (QD)
Intervention Type
Biological
Intervention Name(s)
Pegasys®
Intervention Description
peginterferon alfa-2a (solution for injection) 180 µg/week
Intervention Type
Drug
Intervention Name(s)
Copegus®
Intervention Description
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
GS-9451
Intervention Description
GS-9451 tablet, 200 mg QD
Intervention Type
Drug
Intervention Name(s)
Tegobuvir placebo
Intervention Description
placebo matching Tegobuvir (GS-9190) capsule BID
Intervention Type
Biological
Intervention Name(s)
Pegasys®
Intervention Description
peginterferon alfa-2a (solution for injection) 180 µg/week
Intervention Type
Drug
Intervention Name(s)
Copegus®
Intervention Description
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
Intervention Type
Drug
Intervention Name(s)
Tegobuvir placebo
Intervention Description
placebo matching Tegobuvir (GS-9190) capsule BID
Intervention Type
Drug
Intervention Name(s)
GS-9451 placebo
Intervention Description
placebo matching GS-9451 tablet QD
Intervention Type
Biological
Intervention Name(s)
Pegasys®
Intervention Description
peginterferon alfa-2a (solution for injection) 180 µg/week
Intervention Type
Drug
Intervention Name(s)
Copegus®
Intervention Description
ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
Primary Outcome Measure Information:
Title
Sustained virologic response
Description
Sustained virologic response (SVR) defined as undetectable hepatitis C virus (HCV) RNA 24 weeks after treatment cessation
Time Frame
24 weeks of off-treatment follow-up
Secondary Outcome Measure Information:
Title
Safety and tolerability of therapy
Description
Safety and tolerability of therapy as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events
Time Frame
Through treatment period and 24 weeks of off-treatment follow-up
Title
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
Title
Viral dynamics and steady state pharmacokinetics
Description
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
Time Frame
Through Week 4 of therapy
Title
Durability of response in subjects who achieve SVR
Time Frame
36 months following Week 72

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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