Hepatitis C, Chronic Clinical Trial
Official title:
A Long Term Follow-up Registry Study of Subjects Who Did Not Achieve Sustained Virologic Response in Gilead-Sponsored Trials in Subjects With Chronic Hepatitis C Infection
| Verified date | May 2018 |
| Source | Gilead Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This Registry is designed to obtain long term data on participants who have failed to achieve sustained virologic response (SVR) while receiving at least one Gilead oral antiviral agent (OAV) in a previous Gilead-sponsored hepatitis C virus (HCV) study.
| Status | Completed |
| Enrollment | 570 |
| Est. completion date | April 9, 2018 |
| Est. primary completion date | April 9, 2018 |
| 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 OAV - Have failed to achieve an SVR in a previous Gilead-sponsored study, as defined in the original treatment protocol - Provide written, informed consent - Be willing and able to comply with the visit schedule 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 | Flinders Medical Centre | Bedford Park | South Australia |
| Australia | Royal Prince Alfred Hospital | Camperdown | New South Wales |
| Australia | Canberra Specialist Centre | Canberra | Australian Capital Territory |
| Australia | 102 Burton Street | Darlinghurst | New South Wales |
| Australia | East Sydney Doctors | Darlinghurst | New South Wales |
| Australia | St Vincent's Public Hospital Sydney | Darlinghurst | New South Wales |
| Australia | St Vincent's University Hospital | Fitzroy | |
| Australia | Footscray Hospital | Footscray | Victoria |
| Australia | Austin Health | Heidelberg | Victoria |
| Australia | Liverpool Hospital | Liverpool | New South Wales |
| Australia | Alfred Hospital | Melbourne | Victoria |
| Australia | Alfred Hospital - Infectious Disease Unit | Melbourne | Victoria |
| Australia | Monash Medical Centre | Melbourne | Victoria |
| Australia | Fiona Stanley Hospital | Murdoch | Western Australia |
| Australia | Royal Perth Hospital | Perth | Western Australia |
| Australia | Royal Brisbane & Women's Hospital | QLD | |
| Australia | Westmead Hospital | Westmead | New South Wales |
| Australia | Greenslopes Private Hospital | Woolloongabba | Queensland |
| Australia | Princess Alexandra Hospital | Woolloongabba | |
| Austria | Medizinische Universität Graz | Graz | Styria |
| Austria | Wilhelminenspital der Stadt Wien | Wien | Vienna |
| Canada | University of Calgary | Calgary | |
| Canada | University of Alberta | Edmonton | |
| Canada | Hopital Saint-Luc du CHUM | Montreal | |
| Canada | Inspiration Research Limited | Toronto | Ontario |
| Canada | Toronto General Hospital | Toronto | |
| Canada | Toronto Western Hospital | Toronto | |
| Canada | GIRI GI Research Institute | Vancouver | |
| Canada | Gordon & Leslie Diamond Health Care Centre | Vancouver | |
| Canada | LAIR Centre | Vancouver | |
| Canada | University of British Colombia | Vancouver | |
| Canada | Vancouver Infectious Disease Research and Care Centre | Vancouver | British Columbia |
| Canada | University of Manitoba, Health Sciences Center | Winnipeg | |
| Czechia | Remedis, s.r.o., Nestátní zdravotnické zarízení, Vladimírova 10 | Praha 4 | |
| Czechia | Klinmed, 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 | Service des Maladies de l'Appareil Digestif et de la nutrition | Lille | NORD Pas-de-calais |
| 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 Salpétrière, Service des Maladies Infectieuses | Paris | Ile-de-france |
| France | Hopital Pitie-Salpetriere | Paris | |
| France | Hôpital Saint Louis, Services des Maladies Infectieuses | Paris | |
| France | Hôpital Saint-Antoine | Paris cedex 12 | Ile-de-france |
| France | Service Maladies Infectieuses | Paris Cedex 12 | Ile-de-france |
| France | Hôpital Bichat-Claude Bernard | Paris cedex 18 | Ile-de-france |
| France | Hôpital Haut-Lévêque, CHU Bordeaux | Pessac Cedex | Aquitaine |
| France | Hopital Pontchaillou | Rennes Cedex 9 | |
| France | C.H.U. Strasbourg - Hôpital Hautpierre - Hématologie | Strasbourg | |
| France | CHU de Nancy | Vandoeuvre | |
| Germany | Charite Campus Virchow-Klinikum | Berlin | |
| Germany | Leber- and Studienzentrum am Checkpoint | Berlin | |
| Germany | MIB Dienstleistung GmbH | Berlin | |
| Germany | Seestrasse 13 | Berlin | |
| Germany | Universitätsklinikum Bonn | Bonn | |
| Germany | Center for HIV and Hepatogastroenterology | Dusseldorf | |
| Germany | Medizinisches Versorgungszentrum | Düsseldorf | Nordrhein-westfalen |
| Germany | Universitätsklinikum Düsseldorf | Düsseldorf | Nordrhein-westfalen |
| Germany | Medizinisches Zentrum - Klinik für Gastroenterologie und Hepatologie | Essen | Nordrhein-westfalen |
| Germany | Klinikum der Johann Wolfgang Goethe Universitaet | Frankfurt | |
| Germany | Klinikum der Johann Wolfgang-Goethe-Universität | Frankfurt | |
| Germany | Universitätsklinikum Frankfurt | Frankfurt | |
| Germany | Infektiologikum | Frankfurt am Main | Hessen |
| Germany | Universitätsklinikum Frankfurt | Frankfurt am Main | Hessen |
| Germany | Albert-Ludwigs-Universität | Freiburg | Baden-wuerttemberg |
| Germany | Medizinische Universitatsklinik | Freiburg | |
| Germany | Bertoldstrasse 48 | Freiburg im Breisgau | Baden-wuerttemberg |
| Germany | Asklepios Klinik St. Georg | Hamburg | |
| Germany | Institut für interdisziplinäre Medizin Studien GmbH an der Asklepiosklinik Saint Georg | Hamburg | |
| Germany | Universitatsklinikum Hamburg-Eppendorf | Hamburg | |
| Germany | CRC Hannover | Hannover | Niedersachsen |
| Germany | Medizinische Hochschule Hannover | Hannover | |
| Germany | Klinikum der Universität Heidelberg | Heidelberg | |
| Germany | Medizinische Universitätsklinik IV (Krehl Klinik) Abt. Gastroenterologie und Infektionskrankhen | Heidelberg | Baden-wuerttemberg |
| Germany | Gastroenterologische Gemeinschaftspraxis | Herne | Nordrhein-westfalen |
| Germany | Gastroenterologische Gemeinschaftspraxis Kiel | Kiel | |
| Germany | Klinik für Gastroenterologie und Hepatologie am Abdominalzentrum | Köln | Nordrhein-westfalen |
| Germany | University of Leipzig | Leipzig | |
| Germany | Johannes Gutenberg University Hospital | Mainz | |
| Germany | Mainz University | Mainz | |
| Germany | Klinikum Innenstadt der LMU Munchen | Muenchen | |
| Germany | Universitätsklinik Würzburg | Wüerzburg | |
| Germany | Universitätsklinikum Würzburg - Med Klinik und Poliklinik | Wurzburg | |
| 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 | Milano | |
| Italy | Azienda Ospedaliera Ospedale Niguarda Ca' Granda | Milano | |
| Italy | Dipartimento Polispecialistico - Malattie Infetive | 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 | Malattie Infettive - Epatologia | Roma | |
| Italy | Casa Sollievo della Sofferenza Hospital | 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 | Auckland City Hospital | Grafton | Auckland |
| New Zealand | Auckland Clinical Studies Limited | Grafton | Auckland |
| New Zealand | Middlemore Hospital | Grafton | Auckland |
| New Zealand | Urosurgery | Hamilton | |
| New Zealand | Waikato Hospital (District Health Board) | Hamilton | |
| New Zealand | Wellington Hospital | Newton | WGN |
| New Zealand | Bay of Plenty Clinical School | Tauranga | BAY OF Plenty |
| New Zealand | Wellington Hospital | Wellington | |
| Poland | Wojewódzki Szpital Specjalistyczny im. Kazimierza Dluskiego w Bialymstoku | Bialystok | Podlaskie |
| Poland | SP ZOZ Wojewodzki Szpital Zakazny w Warszawie | Chorzow | |
| Poland | Szpital Specjalistyczny w Chorzowie | Chorzów | Slaskie |
| Poland | Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego | Lodz | |
| Poland | ID Clinic | Myslowice | Slaskie |
| Poland | NZOZ Pol-SaNa-Med | Myslowice | |
| Poland | Oddzial Dzienny | Warszawa | Mazowieckie |
| Poland | SP ZOZ Wojewódzki Szpital Zakazny | Warszawa | Mazowieckie |
| Poland | Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy | Wroclaw | Dolnoslaskie |
| Poland | NZOZ Centrum Badan Klinicznych | Wroclaw | Dolnoslaskie |
| Puerto Rico | Chattanooga Hem/Oncology Ass (SCRI) | San Juan | |
| 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 Moncloa, Servicio de Enfermedades Infecciosas | Madrid | |
| Spain | Hospital Universitario 12 de Octubre | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Hospital Universitario La Paz | Madrid | |
| Spain | Paseo de la Castellana nº 261 | Madrid | |
| Spain | C / Manuel de Falla | Majadahonda | Madrid |
| Spain | Hospital Puerta de Hierro Majadahonda | Majadahonda | Madrid |
| Spain | Hospital Universitario Nuestra Señora de Valme | Sevilla | |
| Spain | Hospital Universitario Nuestra Señora de Valme | Sevilla | |
| Spain | Avenida Tres Cruces s/n | Valencia | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Sweden | Sahlgrenska Universitetssjukhuset, Östra Sjukhus | Göteborg | |
| Sweden | Sahlgrenska Universitetssjukhuset, Östra sjukhuset | Göteborg | Vastra Gotaland |
| Sweden | Skånes Universitetssjukhus | Lund | |
| Sweden | Skånes Universitetssjukhus i Lund | Lund | |
| Sweden | Skånes Universitetssjukhus, Malmö | Malmö | |
| Sweden | Karolinska Universitetssjukhuset Solna | Solna | |
| United Kingdom | University of Birmingham and Queen Elizabeth Hospital Birmingham | Birmingham | England |
| United Kingdom | Marlborough Street | Bristol | |
| United Kingdom | Southampton University Hospitals NHS Trust, Southampton General Hospital | Hampshire | 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 | St George Hospital | London | England |
| United Kingdom | Westminster Bridge Road | London | England |
| United Kingdom | North Manchester General Hospital | Manchester | England |
| United Kingdom | Queen's Medical Centre Campus | Nottingham | England |
| United Kingdom | John Radcliffe Hospital | Oxford | England |
| United Kingdom | Derriford Hospital | Plymouth | |
| United States | University of New Mexico | Albuquerque | New Mexico |
| United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
| 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 | Texas Clinical Research Institute, LLC | Arlington | Texas |
| United States | The North Texas Research Institute | Arlington | Texas |
| United States | Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina |
| United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
| United States | Digestive Healthcare of Georgia | Atlanta | Georgia |
| United States | Emory University | Atlanta | Georgia |
| United States | University of Colorado | Aurora | Colorado |
| United States | Austin Hospital | Austin | Texas |
| 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 | Johns Hopkins University | Baltimore | Maryland |
| United States | Mercy Medical Center | Baltimore | Maryland |
| United States | Gastroenterology Associates, LLC | Baton Rouge | Louisiana |
| United States | Medical Development Centers, LLC | Baton Rouge | Louisiana |
| 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 | Pointe West Infectious Diseases d/b/a Bach and Godofsky Infectious Diseases | Bradenton | Florida |
| United States | Lahey Clinic Medical Center | Burlington | Massachusetts |
| United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
| United States | Medical College of Wisconsin | Chicago | Illinois |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | University of Chicago | Chicago | Illinois |
| United States | Southern California Medical Group | Coronado | California |
| United States | West Coast Clinical Trials, LLC | Costa Mesa | California |
| United States | Baylor University Medical Center | Dallas | Texas |
| United States | Methodist Transplant Physicians | Dallas | Texas |
| United States | Nicholaos C. Bellos | Dallas | Texas |
| United States | UT Southwestern Medical Center at Dallas | Dallas | Texas |
| United States | UC Davis Medical Center | Davis | California |
| United States | Infectious Disease Specialists of Atlanta | Decatur | Georgia |
| United States | Henry Ford Health System | Detroit | Michigan |
| United States | Digestive Health Specialists | Dothan | Alabama |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | South Denver Gastroenterology | Englewood | Colorado |
| United States | Metropolitan Research | Fairfax | Virginia |
| 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 | Gainesville | Florida |
| United States | Gastro One | Germantown | Tennessee |
| United States | Gastroenterology Center of the MidSouth, P.C. | Germantown | Tennessee |
| United States | Memphis Gastroenterology Group | Germantown | Tennessee |
| United States | ID Care, Inc. | Hillsborough | New Jersey |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Kelsey Research Foundation | Houston | Texas |
| United States | Research Specialists of Texas | Houston | Texas |
| United States | St. Luke's Episcopal Hospital | 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 | Indiana University School of Medicine | Indianapolis | Indiana |
| United States | Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana |
| United States | Binghamton Gastroenterology Associates | Johnson City | New York |
| United States | Kansas City Gastroenterology and Hepatology | Kansas City | Missouri |
| United States | University of Kansas Medical Center | Kansas City | Kansas |
| United States | University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas |
| United States | Kaiser Permanente Institute for Health Research | La Jolla | California |
| United States | Scripps Clinic | La Jolla | California |
| United States | University of California San Diego | La Jolla | California |
| United States | eStudySite | La Mesa | California |
| United States | Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania |
| United States | Impact Clinical Trials | Las Vegas | Nevada |
| United States | VA Long Beach Healthcare System | Long Beach | California |
| United States | 8631 West 3rd Street | Los Angeles | California |
| United States | Anthony Mills MD, Inc | Los Angeles | California |
| United States | California Liver Institute | Los Angeles | California |
| United States | Cedars-Sinai Medical Center | Los Angeles | California |
| United States | Kaiser Permanente of Colorado | Los Angeles | California |
| United States | Peter J. Ruane, MD, Inc. | Los Angeles | California |
| United States | Veterans Administration Wadsworth Medical Center | Los Angeles | California |
| United States | Wisconsin Hospital and Clinic | Madison | Wisconsin |
| United States | North Shore University Hospital | 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 Miller School of Medicine | Miami | Florida |
| United States | Research Center at Affiliates in Gastroenterology | Morristown | New Jersey |
| United States | Nashville Gastrointestinal Specialists, Inc | Nashville | Tennessee |
| United States | Nashville Medical Research Institute | Nashville | Tennessee |
| United States | Quality Medical Research, PLLC | Nashville | Tennessee |
| United States | Yale University School of Medicine | New Haven | Connecticut |
| United States | Advanced Research Institute | New Port Richey | Florida |
| United States | Columbia University Medical Center | New York | New York |
| United States | Concorde Medical Group PLLC | New York | New York |
| United States | Mount Sinai Beth Israel | New York | New York |
| United States | Mount Sinai School of Medicine | New York | New York |
| United States | Saint Luke's-Roosevelt Hospital Center | New York | New York |
| United States | St. Luke's Roosevelt Hospital | New York | New York |
| United States | Weill Medical College of Cornell Univeristy | New York | New York |
| United States | Saint Michael's Medical Center | Newark | New Jersey |
| 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 | 660 South Fair Oaks Avenue | Pasadena | California |
| United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
| United States | Philadelphia FIGHT | Philadelphia | Pennsylvania |
| United States | University of Pennsylvania | 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 | Minnesota Gastroenterology, P.A. | Plymouth | Minnesota |
| 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 | Liver Institute of Virginia, Bon Secours Health System | Richmond | Virginia |
| United States | Virginia Commonwealth University Medical Center | Richmond | Virginia |
| United States | 200 1st st SW | Rochester | Minnesota |
| United States | Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester | Rochester | New York |
| United States | UC 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, P.A. | Saint Paul | Minnesota |
| United States | Lifetree Clinical Research | Salt Lake City | Utah |
| United States | PRA Health Sciences | Salt Lake City | Utah |
| United States | University of Utah Pediatric Pulmonology | Salt Lake City | Utah |
| United States | Alamo Medical Research | San Antonio | Texas |
| United States | The Texas Liver Institute | San Antonio | Texas |
| United States | Medical Associates Research Group, Inc. | San Diego | California |
| United States | Research and Education, Inc. | San Diego | California |
| United States | University of California San Diego | San Diego | California |
| United States | California Pacific Medical Center | San Francisco | California |
| United States | Quest Clinical Research | San Francisco | California |
| United States | San Francisco General Hospital | San Francisco | California |
| United States | University of California San Francisco | San Francisco | California |
| United States | University of California, San Francisco School of Medicine | San Francisco | California |
| United States | San Jose Gastroenterology | San Jose | 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 | The Research Institute | Springfield | Massachusetts |
| United States | Saint Joseph's Hospital | Tampa | Florida |
| United States | St. Joseph's Comprehensive Research Institute | Tampa | Florida |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Los Angeles BioMedical Institute at Harbor-UCLA Medical Center | Torrance | California |
| United States | Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California |
| United States | 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 | Whitman Walker Clinic | 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 | Westchester Medical Center | Yonkers | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Gilead Sciences |
United States, Australia, Austria, 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 with at least one drug resistant mutation (DRM) loss from enrollment to end of study by treatment regimen | Up to 3 years | ||
| Secondary | Proportion of participants with DRM loss by unit category, 1, 2, 3,…n, by treatment regimen | Up to 3 years | ||
| Secondary | Average number of DRM loss by treatment regimen | Up to 3 years | ||
| 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 3 years | |
| Secondary | Proportion of participants who develop hepatocellular carcinoma (HCC) through Week 144 by treatment regimen | Up to 144 weeks |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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Low-dose Peg-interferon Plus Ribavirin (IFN/RBV) for Prevention of Hepatocellular Carcinoma (HCC) Recurrence in Patients Who Had Surgery to Remove Primary HCC
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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
|
Phase 2 |