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The purpose of this study is to determine the safety and effectiveness of viramidine to ribavirin in chronic hepatitis C patients who have never before received treatment.
Compare the efficacy and safety of viramidine 600 mg twice a day (BID) versus ribavirin 1000/1200 mg/day, both drugs administered in combination with pegylated interferon alfa-2a to treatment-naive patients with chronic hepatitis C (CHC)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viramidine | Drug | |||
| Ribavirin | Drug | |||
| pegylated interferon alfa-2a | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| - Efficacy: Undetectable plasma HCV RNA (less than 100 copies/mL) at the end of the 24-week post-treatment follow-up period. | ||
| - Safety: The proportion of patients with hemoglobin less than 10 g/dL at any time during treatment or at least 2.5 g/dL drop from baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| - Efficacy: Undetectable plasma HCV RNA at treatment week 24 | ||
| - Efficacy: Undetectable or at least a 2-log drop from baseline at treatment weeks 12 and 24 | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ralph T. Doyle | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724-5136 | United States | ||
| UCSF Fresno- Internal Medicine |
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| - Safety: Monitoring of adverse events |
| - Safety: Monitoring of abnormal changes in laboratory parameters that are not disease-related |
| Fresno |
| California |
| 93702 |
| United States |
| Keck School of Medicine, University of Southern California | Los Angeles | California | 90033 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Orange Coast Medical Group | Newport Beach | California | 92633 | United States |
| University of California Davis Medical Center | Sacramento | California | 95817 | United States |
| Research and Education, Inc. | San Diego | California | 92115 | United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| San Mateo Medical Center | San Mateo | California | 94403 | United States |
| University of Colorado Health Sciences Center | Denver | Colorado | 80262 | United States |
| Rocky Mountain Gastroenterology | Lakewood | Colorado | 80215 | United States |
| University of Connecticut | Farmington | Connecticut | 06030 | United States |
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307 | United States |
| Bach and Godofsky | Bradenton | Florida | 34205 | United States |
| Mayo Clinic Jacksonville | Jacksonville | Florida | 32216 | United States |
| Atlanta Academic Research Group | Atlanta | Georgia | 30033 | United States |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30308 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 | United States |
| University of Louisville | Louisville | Kentucky | 40202 | United States |
| Louisiana State University Memorial Hospital | New Orleans | Louisiana | 70115 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Johns Hopkins | Baltimore | Maryland | 21205 | United States |
| Johns Hopkins University Medical Center | Baltimore | Maryland | 21287 | United States |
| Maryland Digestive Disease Research | Laurel | Maryland | 20707 | United States |
| Future Care Studies/Northgate Medical | Springfield | Massachusetts | 01107 | United States |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Bradley Freilich, MD | Kansas City | Missouri | 64131 | United States |
| Saint Louis University School of Medicine | St Louis | Missouri | 63104 | United States |
| Atlantic Gastroenterology Associates | Egg Harbor | New Jersey | 08234 | United States |
| Regional Clinical Research, Inc. | Johnson City | New York | 13790 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| Cabrini Medical Center | New York | New York | 10029 | United States |
| SUNY Upstate Medical University | Syracuse | New York | 13210 | United States |
| Jacobi Medical Center | The Bronx | New York | 10461 | United States |
| Bronx VA Medical Center | The Bronx | New York | 10468 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Digestive Health Specialists | Winston-Salem | North Carolina | 27103 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45219 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| Research Solutions (SMO) | Tulsa | Oklahoma | 74104 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Radiant Research - Austin | Austin | Texas | 78758 | United States |
| University of Texas | Dallas | Texas | 75390 | United States |
| VA Medical Center | Houston | Texas | 77030 | United States |
| INOVA Fairfax Hospital | Annadale | Virginia | 22003 | United States |
| Kaiser Permanente Medical Center | Falls Church | Virginia | 22046 | United States |
| Hunter Holmes McGuire Medical Center | Richmond | Virginia | 23249 | United States |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | United States |
| Hospital Italiano | Buenos Aires | Buenos Aires | (C1199ACK) | Argentina |
| Fundación CIDEA | Buenos Aires | Buenos Aires | (C1264AAA) | Argentina |
| Hospital Británico | Buenos Aires | Buenos Aires | (C1280AEB) | Argentina |
| Hospital Austral | Pilar | Buenos Aires | (B1629AHJ) | Argentina |
| Hospital Centenario | Rosario | Santa Fe Province | (S2000CFJ) | Argentina |
| Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| The Alfred Hospital | Prahran | Victoria | 3181 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
| University of Alberta | Edmonton | Alberta | T6G 2C8 | Canada |
| University of Manitoba | Winnipeg | Manitoba | R3E 3P4 | Canada |
| Toronto Western Hospital | Toronto | Ontario | M5T 2S8 | Canada |
| CHU Grenoble Hôpital Michallon, Service d'Hépatogastroentérologie | Grenoble | 38043 | France |
| Hopital Saint Joseph Service d'Hépato-gastroentérologie | Marseille | 13285 | France |
| Hôpital de l'Archet 2 Service d'Hépato-Gastroentérologie | Nice | 06202 | France |
| Hôpital Saint Antoine, Service d'Hépato-Gastroentérologie | Paris | 75571 | France |
| C.H.U de Nancy - Hôpital de Brabois Adultes Service d'Hépato-gastroentérologie | Vandouevre Les Nancy | 54511 | France |
| Rambam Medical Center Liver Unit | Haifa | 31096 | Israel |
| Head of Liver Unit, Holy family Hospital | Nazareth | 16100 | Israel |
| Tel Aviv Souraski Medical Center, Liver Unit, Department of Gastro-enterology | Tel Aviv | 64239 | Israel |
| Malattie Infettive, Azienda Ospedaliera di Busto Arsizio | Busto Arsizio | 21052 | Italy |
| Az. Osp. Universitaria Policlinico "Paolo Giaccone" | Palermo | 90127 | Italy |
| IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS | Rome | 00149 | Italy |
| Divisione di Gastroenterologia, Azienda Ospedaliera S.Giovanni Battista | Torino | 20126 | Italy |
| Wojewodzki Szpital Obserwacyjno-Zakazny im. T. Browicza | Bydgoszcz | 85-030 | Poland |
| Szpital Specjalistyczny | Chorzów | 41-500 | Poland |
| Katedra Chorob Zakaznych i Hepatologii Collegium Medicum Uniwersytetu Jagiellonskiego | Krakow | 31-531 | Poland |
| Katedra i Klinika Chorob Zakaznych Pomorskiej Akademii Medycznej | Szczecin | 71-455 | Poland |
| Klinika Chorob Wewnetrznych i Reumatologii CSK MON WIM | Warsaw | 00-909 | Poland |
| Wojewodzki Szpital Zakazny | Warsaw | 01-201 | Poland |
| Fundacion de Investigacion de Diego | Santurce | 00909 | Puerto Rico |
| Russian State Medical University | Moscow | 115516 | Russia |
| City Hospital of Infectious Diseases #10 | Saint Petersburg | 190020 | Russia |
| Department of gastroenterology, Russian Military Academy; Regional Military Clinical Hospital №442 | Saint Petersburg | 193163 | Russia |
| City Hospital of Infectious Diseases #30 | Saint Petersburg | 193167 | Russia |
| Department of infectious diseases, Russian Military Academy | Saint Petersburg | 194175 | Russia |
| Smolensk Medical Academy | Smolensk | 214018 | Russia |
| Hospital Universitario Germans Trias i Pujol | Badalona | 08916 | Spain |
| Hospital Santa Creu I Sant Pau | Barcelona | 08025 | Spain |
| Hospital Universitario La Princesa | Madrid | 28006 | Spain |
| Hospital Carlos III | Madrid | 28029 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Liver and Hepatobiliary Unit, Queen Elizabeth Hospital | Birmingham | B15 2TH | United Kingdom |
| Liver Unit, Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C026956 | taribavirin |
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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