Back to resultsA 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
Primary Purpose
Chronic Hepatitis C Infection
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GS-9190
GS-9256
Pegasys®
Copegus®
GS-9190 placebo
GS-9256
Pegasys®
Copegus®
GS-9190 placebo
GS-9256 placebo
Pegasys®
Copegus®
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis C Infection 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-9256
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 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
Sites / Locations
- Mayo Clinic
- Advanced Clinical Research Institute
- Scripps Clinic
- Cedars-Sinai Medical Center
- Medical Associates Research Group
- Kaiser Permanente
- California Pacific Medical Center
- South Denver Gastroenterology
- University of Florida
- University of Miami Center for Liver Diseases
- Orlando Immunology Center
- Bach and Godofsky Infectious Diseases
- Atlanta Gastroenterology Associates
- Emory University, Infectious Disease Clinic
- Northwestern Memorial Hospital
- Indiana University
- Gastroenterology Associates, LLC
- Johns Hopkins University
- Beth Israel Deaconess Medical Center
- Henry Ford Health System
- Southwest CARE Center
- North Shore University Hospital
- Concorde Medical Group
- Cornell University Gastroenterology & Hepatology
- Mount Sinai Medical Center
- Duke University Medical Center
- University Hospitals Case Medical Center
- University Gastroenterology
- Memphis Gastroenterology Group
- The North Texas Research Institute
- UT Southwestern Medical Center at Dallas
- Alamo Medical Research
- Metropolitan Research
- Liver Institute of Virginia, Bon Secours
- Digestive and Liver Disease Specialists
- Virginia Mason Medical Center, Digestive Disease Institute
- Medizinische Universität Graz
- LKH Innsbruck
- Krankenhaus der Elisabethinen Linz GmbH
- AKH der Stadt Wien
- Wilhelminenspital der Stadt Wien
- SGS - Clinical Pharmacology Unit Antwerpen
- ULB Erasme
- UCL Saint Luc
- UZ Antwerp
- CHU Sart Tilman
- Heritage Medical Research Clinic
- University of Alberta, Division of Gastroenterology
- Downtown ID Clinic
- Gordon & Leslie Diamond Health Care Centre
- GI Research Institute
- John Buhler Research Centre
- London Health Sciences Centre
- Ottawa Hospital, Division of Infectious Diseases
- Toronto General Hospital
- Toronto Western Hospital
- University Hospital Brno
- Melnik Hospital
- University Hospital Plzen
- Klinmed, s.r.o.
- Institute of Clinic and Experimental Medicine
- Association of Physicians for Infection Diseases
- Beaujon Hospital
- Henri Mondor Hospital
- Claude Huriez Hospital
- Hotel Dieu Hospital
- Saint Joseph Hospital
- Nancy University Hospital Center
- Charite University Medicine
- University Hospital Bonn
- University Hospital Essen
- Klinikum der Johann Wolfgang Goethe-Universität
- University Hospital Freiburg
- Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH
- Medizinische Hochschule Hannover
- University hospital Heidelberg
- University Hospital Leipzig
- Johannes Gutenberg University Hospital
- Ludwig-Maximilians-University Munich
- Epatologia, Azienda Ospedaliero "Spedali Civili"
- U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
- Medicina Generale - Azienda Ospedaliera di Padova
- U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone
- Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria
- Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista
- Wojewodzki Szpital Specjalistyczny im. K. Dluskiego Oddzial Obserwacyjno-Zakazny
- Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza Oddział Obserwacyjno-Zakazny
- Szpital Specjalistyczny w Chorzowie
- Niepubliczny Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia
- 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 Wojewodzki Szpital Zespolony w Szczecinie
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddzial Dzienny
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X
- Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie
- EMC Instytut Medyczny S.A.
- Hospital Universitari Vall d'Hebrón
- Hospital Clínico Universitario San Cecilio
- Hospital Universitario Ramón y Cajal
- Hospital Universitario Puerta de Hierro Majadahonda
- Hospital Universitario Ntra. Sra. de Valme
- Hospital General Universitario de Valencia
- Queen Elizabeth Hospital
- North Manchester General Hospital
- Royal Liverpool University Hospital
- Barts and The London Hospital
- University College London Hospital
- Kings College Hospital
- Chelsea and Westminster Hospital
- Institute of Cellular Medicine (Hepatology)
- Derriford Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
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-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
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
Outcomes
Primary Outcome Measures
Sustained virologic response (SVR) defined as undetectable HCV RNA 24 weeks after treatment cessation
Secondary Outcome Measures
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
Plasma HCV RNA will be measured at approximately 6, 12, 24, and 36 months after Week 72.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01225380
Brief Title
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
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 Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection
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-9256
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
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
Arm Title
Arm 3
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
GS-9190
Intervention Description
GS-9190 capsule, 20 mg BID, 16 or 24 weeks
Intervention Type
Drug
Intervention Name(s)
GS-9256
Intervention Description
GS-9256 capsule, 150 mg BID, 16 or 24 weeks
Intervention Type
Biological
Intervention Name(s)
Pegasys®
Intervention Description
peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
Intervention Type
Drug
Intervention Name(s)
Copegus®
Intervention Description
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
Intervention Type
Drug
Intervention Name(s)
GS-9190 placebo
Intervention Description
placebo matching GS-9190 capsule BID, 24 weeks
Intervention Type
Drug
Intervention Name(s)
GS-9256
Intervention Description
GS-9256 capsule, 150 mg BID, 24 weeks
Intervention Type
Biological
Intervention Name(s)
Pegasys®
Intervention Description
peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
Intervention Type
Drug
Intervention Name(s)
Copegus®
Intervention Description
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
Intervention Type
Drug
Intervention Name(s)
GS-9190 placebo
Intervention Description
placebo matching GS-9190 capsule BID, 24 weeks
Intervention Type
Drug
Intervention Name(s)
GS-9256 placebo
Intervention Description
placebo matching GS-9256 capsule BID, 24 weeks
Intervention Type
Biological
Intervention Name(s)
Pegasys®
Intervention Description
peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
Intervention Type
Drug
Intervention Name(s)
Copegus®
Intervention Description
ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks
Primary Outcome Measure Information:
Title
Sustained virologic response (SVR) defined as undetectable 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 as measured by frequency of laboratory abnormalities, reported adverse events, and discontinuations due to adverse events
Time Frame
Through up to 48 weeks treatment period and 24 weeks of off-treatment follow-up
Title
Emergence of viral resistance following initiation of therapy with GS-9190 and GS-9256
Time Frame
Through up to 48 weeks 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 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
Time Frame
Through Week 4 of therapy
Title
Long-term assessment of plasma HCV RNA in subjects who achieve SVR
Description
Plasma HCV RNA will be measured at approximately 6, 12, 24, and 36 months after Week 72.
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 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
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
Mayo Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Scripps Clinic
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
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
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami Center for Liver Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Bach and Godofsky Infectious Diseases
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34243
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
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Gastroenterology Associates, LLC
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Johns Hopkins University
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Southwest CARE Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
North Shore University Hospital
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Concorde Medical Group
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
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University Hospitals Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University Gastroenterology
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
Facility Name
Memphis Gastroenterology Group
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
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
39090
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
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
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
SGS - Clinical Pharmacology Unit 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
CHU Sart Tilman
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
University of Alberta, Division of Gastroenterology
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C2
Country
Canada
Facility Name
Downtown ID Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V3S 4N9
Country
Canada
Facility Name
Gordon & Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3P1
Country
Canada
Facility Name
GI Research Institute
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K5
Country
Canada
Facility Name
John Buhler Research Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Ottawa Hospital, Division of Infectious Diseases
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 2S8
Country
Canada
Facility Name
University Hospital Brno
City
Brno
ZIP/Postal Code
625 00
Country
Czech Republic
Facility Name
Melnik Hospital
City
Melnik
ZIP/Postal Code
276 01
Country
Czech Republic
Facility Name
University Hospital Plzen
City
Plzen
ZIP/Postal Code
304 60
Country
Czech Republic
Facility Name
Klinmed, s.r.o.
City
Prague
ZIP/Postal Code
128 00
Country
Czech Republic
Facility Name
Institute of Clinic and Experimental Medicine
City
Prague
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
Association of Physicians for Infection Diseases
City
Usti Nad labem
ZIP/Postal Code
477 01
Country
Czech Republic
Facility Name
Beaujon Hospital
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
Henri Mondor Hospital
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
Claude Huriez Hospital
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hotel Dieu Hospital
City
Lyon
ZIP/Postal Code
69002
Country
France
Facility Name
Saint Joseph Hospital
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Nancy University Hospital Center
City
Vandoeuvre
ZIP/Postal Code
54500
Country
France
Facility Name
Charite University Medicine
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
Ifi - Institut fuer Interdisziplinaere Medizin - Studien und Projekte GmbH
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
Ludwig-Maximilians-University Munich
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Epatologia, Azienda Ospedaliero "Spedali Civili"
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
U.O. Gastroenterologia 1 - Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Medicina Generale - Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
U. O. C. di Gastroenterologia - Azienda Ospedaliero-Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Unità di Malattie Infettive ed Epatologia, Azienda Ospedaliero-Universitaria
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Gastroepatologia - Azienda Ospedaliero-Universitaria S. Giovanni Battista
City
Torino
ZIP/Postal Code
10126
Country
Italy
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 Zaklad Opieki Zdrowotnej "Pol-SaNa-Med" Spolka z ograniczona odpowiedzialnoscia
City
Czeladz
ZIP/Postal Code
41-250
Country
Poland
Facility Name
Wojewodzki Szpital Zespolony w Kielcach
City
Kielce
ZIP/Postal Code
25-736
Country
Poland
Facility Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
City
Krakow
ZIP/Postal Code
31-501
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 Wojewodzki Szpital Zespolony w Szczecinie
City
Szczecin
ZIP/Postal Code
71-455
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
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Zakazny Oddział X
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
EMC Instytut Medyczny S.A.
City
Wroclaw
ZIP/Postal Code
50-220
Country
Poland
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clínico Universitario San Cecilio
City
Granada
ZIP/Postal Code
18012
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Ntra. Sra. de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Queen Elizabeth Hospital
City
Birmingham
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
North Manchester General Hospital
City
Greater Manchester
ZIP/Postal Code
M8 5RB
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
University College London 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
SW109NH
Country
United Kingdom
Facility Name
Institute of Cellular Medicine (Hepatology)
City
Newcastle Upon Tyne
ZIP/Postal Code
NE24HH
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-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
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