Hepatitis C, Chronic Clinical Trial
Official title:
A Long Term Follow-up Registry for Subjects Who Achieve a Sustained Virologic Response to Treatment in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection
| Verified date | August 2018 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This Registry is designed to provide long term clinical and virologic follow up in participants who have achieved sustained virologic response (SVR) while participating in a previous Gilead sponsored hepatitis C virus (HCV) study. This long term follow up study is observational and no treatment is provided for HCV.
| Status | Completed |
| Enrollment | 6625 |
| Est. completion date | January 8, 2018 |
| Est. primary completion date | March 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Key Inclusion Criteria: - Have previously participated in a Gilead-sponsored hepatitis C study and received at least one Gilead oral antiviral agent (OAV) - Have achieved SVR in a Gilead-sponsored study, as defined in the original treatment protocol - Provide written, informed consent - Be willing and able to comply with the visit schedule and protocol-mandated procedures Key Exclusion Criteria: - Individuals planning to start a new course of hepatitis C therapy including any investigational drug or device during the course of the follow-up Registry - History of clinically significant illness or any other major medical disorder that may interfere with follow up, assessments, or compliance with the protocol Note: Other protocol defined Inclusion/Exclusion criteria may apply. |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Australia | Flinders University | Bedford Park | South Australia |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Canberra Specialist Centre | Canberra | Australian Capital Territory |
| Australia | Monash Medical Centre | Clayton | Victoria |
| Australia | Concord Repatriation General Hospital | Concord | New South Wales |
| Australia | East Sydney Doctors | Darlinghurst | New South Wales |
| Australia | Holdsworth House Medical Practice | Darlinghurst | New South Wales |
| Australia | St Vincent's Public Hospital Sydney | Darlinghurst | New South Wales |
| Australia | St. Vincent's Hospital Melbourne | Fitzroy | Victoria |
| Australia | Footscray Hospital | Footscray | Victoria |
| Australia | Fremantle Hospital | Fremantle | Western Australia |
| Australia | Greenslopes Private Hospital | Greenslopes | |
| Australia | Austin Health | Heidelberg | Victoria |
| Australia | Royal Brisbane & Women's Hospital | Herston | |
| Australia | St George Hospital | Kogarah | New South Wales |
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | Alfred Hospital | Melbourne | Victoria |
| Australia | Alfred Hospital | Melbourne | Victoria |
| Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
| Australia | Sir Charles Gairdner Hospital | Nedlands | |
| Australia | The Royal Melbourne Hospital | Parkville | Victoria |
| Australia | Royal Perth Hospital | Perth | |
| Australia | Westmead Hospital | Westmead | New South Wales |
| Australia | Princess Alexandra Hospital | Woolloongabba | |
| Austria | Medizinische Universität Graz | Graz | Styria |
| Austria | Medizinische Universität Wien | Wien | Vienna |
| Austria | Wilhelminenspital der Stadt Wien | Wien | Vienna |
| Belgium | Ziekenhuis Netwerk Antwerpen Campus Stuivenberg | Antwerpen | |
| Belgium | Cliniques Universitaires Saint Luc | Brussels | |
| Belgium | Université Libre de Bruxelles Hôpital Erasme | Brussels | |
| Belgium | AZ Groeninge Kortrijk | Kortrijk | |
| Canada | University of Calgary Liver Unit | Calgary | Alberta |
| Canada | University of Alberta Hospital | Edmonton | Alberta |
| Canada | Centre Hospitalier de L'Universite de Montreal (CHUM) | Montreal | Quebec |
| Canada | Ottawa General Hospital | Ottawa | Ontario |
| Canada | Toronto General Hospital | Toronto | Ontario |
| Canada | Toronto Liver Centre | Toronto | Ontario |
| Canada | Toronto Western Hospital | Toronto | Ontario |
| Canada | GIRI GI Research Institute | Vancouver | British Columbia |
| Canada | Gordon and Leslie Diamond Health Care Centre | Vancouver | British Columbia |
| Canada | Liver and Intestinal Research Center | Vancouver | British Columbia |
| Canada | Vancouver Infectious Disease Research and Care Centre | Vancouver | British Columbia |
| Canada | University of Manitoba | Winnipeg | Manitoba |
| Czechia | Slezska nemocnice v Opave, Infekcni oddeleni | Opava | |
| Czechia | Remedis, s.r.o. | Praha 4 | |
| Czechia | Klin med, s.r.o. | Praha 6 | |
| Estonia | West Tallinn Central Hospital | Talinn | |
| Estonia | Tartu University Hospital | Tartu | |
| France | Centre Hospitalier Universitaire de Grenoble | Cedex 9 | Rhone-alpes |
| France | Centre Hospitalier Universitaire de Clermont-Ferrand | Clermont-Ferrand | Auvergne |
| France | Hopital Beaujon | Clichy Cedex | |
| France | Hôpital Henri Mondor | CRETEIL Cedex | Ile-de-france |
| France | Hôpital Claude Huriez- Service d'Hépato-Gastroentérologie | Lille | NORD Pas-de-calais |
| France | Centre Hospitalier Universitaire (CHU) De Limoges - Hopital Dupuytren | Limoges Cedex | Limousin |
| France | Hôpital-Saint Joseph, Service D'Hépato-Gastroentérologie | Marseille cedex 08 | Provence Alpes COTE D'azur |
| France | Hopital Saint-Eloi | Montpellier | |
| France | Hôpital de I´Archet 2 | Nice | Provence Alpes COTE D'azur |
| France | CHU de Nice - Hôpital l'Archet | Nice cedex 3 | |
| France | Hôpital la Pitié Salpêtrière | Paris | |
| France | Hôpital Saint Louis | Paris | |
| France | Hôpital Saint-Antoine | Paris Cedex 12 | Ile-de-france |
| France | Hôpital Saint-Antoine | Paris cedex 12 | Ile-de-france |
| France | CHU Pitié-Salpêtrière | Paris Cedex 13 | Ile-de-france |
| France | Hôpital Bichat-Claude Bernard | Paris cedex 18 | Ile-de-france |
| France | Hôpital Tenon | Paris Cedex 20 | Ile-de-france |
| France | Hôpital Cochin | Paris, Cedex 14 | |
| France | Centre Hospitalier Universitaire Bordeaux Hôpital Haut-Lévêque | Pessac Cedex | |
| France | Hopital Pontchaillou | Rennes Cedex 9 | |
| France | C.H.U. Strasbourg | Strasbourg | |
| France | CIC Hopital Purpan | Toulouse | Midi-pyrenees |
| France | CIC Hopital Purpan | Toulouse | Midi-pyrenees |
| France | Hopitaux De Brabois | Vandoeuvre-les-Nancy | Limousin, Lorraine |
| France | Hôpital Paul Brousse | Villejuif Cedex | Ile-de-france |
| Germany | Charité Universitätsmedizin Berlin | Berlin | |
| Germany | EPIMED GmbH | Berlin | |
| Germany | Leber- and Studienzentrum am Checkpoint | Berlin | |
| Germany | Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH | Berlin | |
| Germany | Universitäts Bonn | Bonn | |
| Germany | Medizinisches Versorgungszentrum | Düsseldorf | Nordrhein-westfalen |
| Germany | Universitätsklinikum Düsseldorf | Düsseldorf | Nordrhein-westfalen |
| Germany | Universitätsklinikum Essen | Essen | Nordrhein-westfalen |
| Germany | Universitätsklinikum Frankfurt | Frankfurt | |
| Germany | Infektiologikum Frankfurt | Frankfurt am Main | Hessen |
| Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | Hessen |
| Germany | Albert-Ludwigs-Universität | Freiburg | Baden-wuerttemberg |
| Germany | PraxisZentrum für Gastroenterologie und Endokrinologie | Freiburg im Breisgau | Baden-wuerttemberg |
| Germany | Asklepios Klinik St. Georg | Hamburg | |
| Germany | Universitatsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | Medizinische Hochschule Hannover | Hannover | |
| Germany | Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen | Heidelberg | Baden-wuerttemberg |
| Germany | Gastroenterologische Gemeinschaftspraxis | Herne | Nordrhein-westfalen |
| Germany | Gastroenterologische Gemeinschaftspraxis Kiel Preetzer | Kiel | |
| Germany | Klinikum der Universität zu Köln | Köln | Nordrhein-westfalen |
| Germany | University of Leipzig | Leipzig | |
| Germany | Mainz University | Mainz | |
| Germany | Centrum für Interdisziplinäre Medizin | Muenster | Nordrhein-westfalen |
| Germany | Medizinische Klinik und Poliklinik III | München | Bayern |
| Italy | Azienda Ospedaliera Papa Giovanni XXIII | Bergamo | |
| Italy | Azienda Ospedaliera di Bologna - Policlinico S. Orsola Malpighi | Bologna | |
| Italy | Azienda Ospedaliera S. Orsola - Malpighi | Bologna | |
| Italy | Ente Ospedaliero Ospedali Galliera di Genova | Genova | |
| Italy | Azienda Ospedaliera - Polo Universitario Luigi Saco | Milano | |
| Italy | Azienda Ospedaliera Ospedale Niguarda Ca' Granda | Milano | |
| Italy | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | |
| Italy | Ospedale San Raffaele-IRCCS, Centro San Luigi - San Raffaele Turro, Unità Operativa di Malattie Infettive | Milano | |
| Italy | Azienda Ospedaliera Padova, U.O.C. Cardiologia | Padova | |
| Italy | Azienda Ospedaliera-universitaria Policlinico P. Giaccone | Palermo | |
| Italy | Azienda Ospedaliero Universitaria di Parma | Parma | |
| Italy | Fondazione Policlinico Tor Vergata | Roma | |
| Italy | Instituto Nationale Per Le Malattie Infettive "Lazzaro Spallanzani" | Roma | |
| Italy | Ospedale Casa Sollievo della Sofferenza | San Giovanni Rotondo | Foggia |
| Italy | Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino | |
| Netherlands | Academisch Medisch Centrum | Amsterdam | Noord-holland |
| Netherlands | Leiden Universitair Medisch Centrum | Leiden | Zuid-holland |
| Netherlands | Universitair Medisch Centrum Sint Radboud | Nijmegen | |
| Netherlands | Erasmus Medisch Centrum | Rotterdam | Zuid-holland |
| New Zealand | Christchurch Hospital | Christchurch | |
| New Zealand | Dunedin Hospital | Dunedin | |
| New Zealand | Auckland City Hospital | Grafton | Auckland |
| New Zealand | Auckland Clinical Studies Limited | Grafton | Auckland |
| New Zealand | Urosurgery | Hamilton | |
| New Zealand | Wellington Hospital | Newtown | WGN |
| New Zealand | Bay of Plenty Clinical School | Tauranga | BAY OF Plenty |
| Poland | Wojewódzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku | Bialystok | Podlaskie |
| Poland | Szpital Specjalistyczny w Chorzowie | Chorzów | Slaskie |
| Poland | Spzoz Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego W Lodzi | Lodz | |
| Poland | ID Clinic Arkadiusz Pisula | Myslowice | Slaskie |
| Poland | SP ZOZ Wojewódzki Szpital Zakazny | Warszawa | Mazowieckie |
| Poland | Centrum Badan Klinicznych | Wroclaw | Dolnoslaskie |
| Puerto Rico | Clinical Research Puerto Rico | San Juan | |
| Puerto Rico | Fundacion De Investigacion De Diego | San Juan | |
| Spain | Hospital Clinic I Provincial de Barcelona | Barcelona | |
| Spain | Hospital Clinic I Provincial de Barcelona | Barcelona | |
| Spain | Hospital General Universitario Gregorio Marañon | Madrid | |
| Spain | Hospital Ramón y Cajal | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Puerta de Hierro Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Clínico Universitario Virgen de la Victoria | Málaga | Malaga |
| Spain | Hospital Universitario Marques de Valdecilla | Santander | |
| Spain | Hospital Universitario Nuestra Señora de Valme | Sevilla | |
| Spain | Hospital Universitario Nuestra Señora de Valme | Sevilla | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Sweden | Sahlgrenska Universitetssjukhuset, Östra Sjukhus | Göteborg | |
| Sweden | Skånes Universitetssjukhus i Lund | Lund | |
| Sweden | Skånes Universitetssjukhus, | Malmö | |
| Sweden | Karolinska University Hospital Huddinge | Stockholm | |
| United Kingdom | University of Birmingham and Queen Elizabeth Hospital Birmingham | Birmingham | England |
| United Kingdom | Bristol Royal Infirmary | Bristol | England |
| United Kingdom | Chelsea and Westminster Hospital NHS Foundation Trust | London | England |
| United Kingdom | Guy's and Saint Thomas NHS Foundation Trust | London | England |
| United Kingdom | Imperial College Healthcare NHS Trust | London | England |
| United Kingdom | King's College Hospital | London | England |
| United Kingdom | Royal Free London NHS Foundation Trust | London | England |
| United Kingdom | St George Hospital | London | England |
| United Kingdom | North Manchester General Hospital | Manchester | England |
| United Kingdom | Nottingham University Hospitals NHS Trust | Nottingham | England |
| United Kingdom | John Radcliffe Hospital | Oxford | England |
| United Kingdom | Derriford Hospital | Plymouth | England |
| United Kingdom | Queen Alexandra Hospital | Portsmouth | England |
| United Kingdom | Southampton University Hospitals NHS Trust, Southampton General Hospital | Southampton | England |
| United States | University of New Mexico | Albuquerque | New Mexico |
| United States | Lehigh Valley Health Network, Network Office of Research and Innovation | Allentown | Pennsylvania |
| United States | Advanced Clinical Research Institute, LLC | Anaheim | California |
| United States | University of Michigan Medical Center | Ann Arbor | Michigan |
| United States | Metropolitan Research | Annandale | Virginia |
| United States | The North Texas Clinical Research Institute | Arlington | Texas |
| United States | Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina |
| United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
| United States | Atlanta Medical Center | Atlanta | Georgia |
| United States | Digestive Healthcare of Georgia | Atlanta | Georgia |
| United States | The Emory Clinic | Atlanta | Georgia |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | Central Texas Clinical Research, LLC | Austin | Texas |
| United States | Franco Felizarta, MD | Bakersfield | California |
| United States | Digestive Disease Associates, PA | Baltimore | Maryland |
| United States | Mercy Medical Center | Baltimore | Maryland |
| United States | Delta Research Partners, LLC | Bastrop | Louisiana |
| United States | Gastroenterology Associates, LLC | Baton Rouge | Louisiana |
| United States | Medical Development Centers, LLC | Baton Rouge | Louisiana |
| United States | Comprehensive Clinical Research | Berlin | New Jersey |
| United States | Binghamton Gastroenterology Associates, PC | Binghamton | New York |
| United States | Birmingham Gastroenterology Associates | Birmingham | Alabama |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | Community Research Initiative of New England | Boston | Massachusetts |
| United States | Massachusetts General Hospital | Boston | Massachusetts |
| United States | Graves-Gilbert Clinic | Bowling Green | Kentucky |
| United States | Bach and Godofsky Infectious Diseases | Bradenton | Florida |
| United States | Bronx Veteran's Affairs Medical Center | Bronx | New York |
| United States | Lahey Clinic Medical Center | Burlington | Massachusetts |
| United States | University of North Carolina | Chapel Hill | North Carolina |
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Carolinas Medical Center | Charlotte | North Carolina |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | Ruth M. Rothstein CORE Center | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | University of Cincinnati | Cincinnati | Ohio |
| United States | University of Maryland | College Park | Maryland |
| United States | University of Miami - Dept of Neurology | Coral Gables | Florida |
| United States | Southern California Liver Centers | Coronado | California |
| United States | West Coast Clinical Trials, LLC | Costa Mesa | California |
| United States | Baylor Endocrine Center | Dallas | Texas |
| United States | Methodist Dallas Medical Center | Dallas | Texas |
| United States | Southwest Infectious Disease Clinical Research, Inc | Dallas | Texas |
| United States | UT Southwestern Medical Center | Dallas | Texas |
| United States | UT Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | Dekalb Gastroenterology Associates, LLC | Decatur | Georgia |
| United States | Infectious Disease Specialists of Atlanta, PC | Decatur | Georgia |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Digestive Health Specialists of the Southeast, PA | Dothan | Alabama |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | South Denver Gastroenterology | Englewood | Colorado |
| United States | Inova Fairfax Hospital Center for Liver Diseases | Falls Church | Virginia |
| United States | Cumberland Research Associates, LLC | Fayetteville | North Carolina |
| United States | University of Florida Hepatology Research at CTRB | Gainesville | Florida |
| United States | Gastro One | Germantown | Tennessee |
| United States | Memphis Gastroenterology Group | Germantown | Tennessee |
| United States | Gastroenterology Center of Connecticut | Hamden | Connecticut |
| United States | ID Care, Inc. | Hillsborough | New Jersey |
| United States | The Queen's Medical Center-Liver Center | Honolulu | Hawaii |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | CHI Health Reseach Center | Houston | Texas |
| United States | Kelsey Research Foundation | Houston | Texas |
| United States | Research Specialists of Texas | Houston | Texas |
| United States | St. Luke's Health Baylor College of Medicine Medical Center | Houston | Texas |
| United States | Therapeutic Concepts, PA | Houston | Texas |
| United States | University of Texas Health Science Center at Houston | Houston | Texas |
| United States | Indiana University School of Medicine | Indianapolis | Indiana |
| United States | Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana |
| United States | Borland-Groover Clinic | Jacksonville | Florida |
| United States | Kansas City Research Institute, LLC | Kansas City | Missouri |
| United States | The Kansas City Free Health Clinic | Kansas City | Missouri |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | Scripps Clinic Medical Group | La Jolla | California |
| United States | eStudySite | La Mesa | California |
| United States | Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania |
| United States | Gastroenterology Consultants PLC | Live Oak | Texas |
| United States | Long Beach VA Medical Center | Long Beach | California |
| United States | Anthony Mills MD, Inc | Los Angeles | California |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Kaiser Permanente | Los Angeles | California |
| United States | National Research Institute | Los Angeles | California |
| United States | Ruane Clinical Research Group | Los Angeles | California |
| United States | Veterans Administration Wadsworth Medical Center | Los Angeles | California |
| United States | Johns Hopkins University | Lutherville | Maryland |
| United States | University of Wisconsin Hospital and Clinics | Madison | Wisconsin |
| United States | Northwell Health | Manhasset | New York |
| United States | Northwell Health | Manhasset | New York |
| United States | Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia |
| United States | Schleinitz Research and Gastroenterology LLC | Medford | Oregon |
| United States | University of Miami | Miami | Florida |
| United States | Atlantic Research Affiliates, LLC | Morristown | New Jersey |
| United States | Intermountain Medical Center | Murray | Utah |
| United States | Nashville Medical Research Institute | Nashville | Tennessee |
| United States | Quality Medical Research, PLLC | Nashville | Tennessee |
| United States | The Frist Clinic | Nashville | Tennessee |
| United States | Yale University | New Haven | Connecticut |
| United States | Advanced Research Institute | New Port Richey | Florida |
| United States | Columbia Presbyterian Hospital, Columbia University | New York | New York |
| United States | Concorde Medical Group PLLC | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | St. Luke's Roosevelt Hospital | New York | New York |
| United States | Weill Cornell Medical College of Cornell Univeristy | New York | New York |
| United States | Saint Michael's Medical Center | Newark | New Jersey |
| United States | Liver Institute of Virginia | Newport News | Virginia |
| United States | Digestive and Liver Disease Specialists | Norfolk | Virginia |
| United States | eStudySite | Oceanside | California |
| United States | Internal Medicine Specialists | Orlando | Florida |
| United States | Orlando Clinical Research Center | Orlando | Florida |
| United States | Orlando Immunology Center | Orlando | Florida |
| United States | Stanford University | Palo Alto | California |
| United States | Huntington Medical Research Institutes | Pasadena | California |
| United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania Hospital | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania School of Medicine | Philadelphia | Pennsylvania |
| United States | Mayo Clinic | Phoenix | Arizona |
| United States | UPMC Center For Liver Diseases | Pittsburgh | Pennsylvania |
| United States | Veterans Affairs Pittsburgh Healthcare System | Pittsburgh | Pennsylvania |
| United States | Oregon Health & Science University | Portland | Oregon |
| United States | The Miriam Hospital | Providence | Rhode Island |
| United States | University Gastroenterology | Providence | Rhode Island |
| United States | Inland Empire Liver Foundation | Rialto | California |
| United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester | Rochester | New York |
| United States | UC Davis Medical Center | Sacramento | California |
| United States | University of California Davis Medical Center | Sacramento | California |
| United States | Saint Louis University | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Minnesota Gastroenterology | Saint Paul | Minnesota |
| United States | PRA Health Sciences | Salt Lake City | Utah |
| United States | University of Utah | Salt Lake City | Utah |
| United States | The Texas Liver Institute | San Antonio | Texas |
| United States | Kaiser Permanente | San Diego | California |
| United States | Medical Associates Research Group, Inc. | San Diego | California |
| United States | Research and Education, Inc. | San Diego | California |
| United States | University of California at San Diego | San Diego | California |
| United States | University of California San Diego | San Diego | California |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | Kaiser Permanente Center | San Francisco | California |
| United States | Quest Clinical Research | San Francisco | California |
| United States | Silicon Valley Research Institute | San Jose | California |
| United States | Southwest C.A.R.E. Center | Santa Fe | New Mexico |
| United States | Harborview Medical Center | Seattle | Washington |
| United States | Virginia Mason Medical Center | Seattle | Washington |
| United States | The Research Institute | Springfield | Massachusetts |
| United States | Carolinas Center for Liver Disease | Statesville | North Carolina |
| United States | Saint Joseph's Hospital | Tampa | Florida |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center | Torrance | California |
| United States | The University of Arizona | Tucson | Arizona |
| United States | Options Health Research LLC | Tulsa | Oklahoma |
| United States | Digestive Health Specialists | Tupelo | Mississippi |
| United States | The Gastroenterology Group of South Jersey | Vineland | New Jersey |
| United States | Capital Medical Associates, P.C. | Washington | District of Columbia |
| United States | Georgetown University Medical Center | Washington | District of Columbia |
| United States | Whitman-Walker Health | Washington | District of Columbia |
| United States | South Florida Center of Gastroenterology, P.A. | Wellington | Florida |
| United States | Digestive Health Specialists, PA | Winston-Salem | North Carolina |
| United States | Partners in Internal Medicine, PC | Worcester | Massachusetts |
| United States | University of Massachusetts | Worcester | Massachusetts |
| United States | Westchester Digestive Disease Group | Yonkers | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Australia, Austria, Belgium, Canada, Czechia, Estonia, France, Germany, Italy, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Sweden, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of participants maintaining SVR at Week 144 by treatment regimen | Week 144 | ||
| Secondary | Proportion of participants with detectable HCV RNA due to reemergence of preexisting virus through Week 144 by treatment regimen | Up to 144 weeks | ||
| Secondary | Proportion of participants with detectable HCV resistance mutations through Week 144 by treatment regimen | Up to 144 weeks | ||
| Secondary | Proportion of participants with detectable HCV RNA due to reinfection through Week 144 by treatment regimen | Up to 144 weeks | ||
| Secondary | Liver disease progression | Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and a-fetoprotein) and observed or reported clinical signs and symptoms. | Up to 144 weeks | |
| Secondary | Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen | Up to 144 weeks |
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Phase 4 | |
| Completed |
NCT00377182 -
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
|
Phase 2 | |
| Completed |
NCT00723632 -
Pharmacoeconomic Study Assessing the Cost of Chronic Hepatitis C Treatment With Peginterferon Alfa-2b (PegIntron) and Ribavirin (Rebetol) in the Czech Republic (Study P04588)(COMPLETED)
|
N/A | |
| Completed |
NCT00217139 -
A Study to Evaluate the Safety and Efficacy of Celgosivir and Peginterferon Alfa-2b, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype 1 Infection
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Phase 2 |