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The study was terminated in the interest of patient safety.
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The objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks and 96 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clevudine | Drug | |||
| Adefovir | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M. Michelle Berrey, MD, MPH | Pharmasset | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | United States | |||
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| Anaheim |
| California |
| 92801 |
| United States |
| Advanced Clinical Research Institution | Anaheim | California | United States |
| Fresno | California | 93710 | United States |
| Fresno | California | United States |
| Los Angeles | California | 90045 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | United States |
| West Gastroenterology Medical Group | Los Angeles | California | United States |
| Los Angeles | California | United States |
| San Clemente | California | United States |
| San Diego | California | 92123 | United States |
| Medical Associates Research Group | San Diego | California | United States |
| Sharp Rees-Stealy Medical Group Inc | San Diego | California | United States |
| San Diego | California | United States |
| Quest Clinical Research | San Francisco | California | 94115 | United States |
| California Pacific Medical Center | San Francisco | California | United States |
| Ucsf/Sfgh | San Francisco | California | United States |
| San Mateo Medical Center | San Mateo | California | United States |
| Norwich | Connecticut | 06360 | United States |
| The William W. Backus Hospital | Norwich | Connecticut | United States |
| Tampa | Florida | 33614 | United States |
| Infectious Disease Research Institute, Inc. | Tampa | Florida | United States |
| Tampa | Florida | United States |
| Liver Center | Honolulu | Hawaii | United States |
| Memphis Gastroenterology Group | Germantown | Indiana | United States |
| Iowa Health-Des Moines | Des Moines | Iowa | United States |
| Tulane Medical Center | New Orleans | Louisiana | United States |
| New Orleans | Louisiana | United States |
| Banks Hepatology Institute | College Park | Maryland | United States |
| Boston | Massachusetts | United States |
| Digestive Health Specialists | Tupelo | Mississippi | United States |
| Saint Louis University | St Louis | Missouri | United States |
| Hillsborough | New Jersey | 08844 | United States |
| UMA Research Department | Binghamton | New York | United States |
| Manhasset | New York | United States |
| Beth Israel Medical Center | New York | New York | United States |
| VAMC/NYU | New York | New York | United States |
| Weill Cornell Medical College | New York | New York | United States |
| New York | New York | United States |
| Asheville | North Carolina | 28801 | United States |
| Asheville Gastroenterology | Asheville | North Carolina | United States |
| Duke University | Durham | North Carolina | United States |
| Cincinnati | Ohio | 45242 | United States |
| Cincinnati | Ohio | United States |
| Portland | Oregon | 97220 | United States |
| Portland | Oregon | 97239 | United States |
| Oregon Heath and Science University (OHSU) | Portland | Oregon | United States |
| The Oregon Clinica P.C. | Portland | Oregon | United States |
| Nashville Gastrointestinal Specialists, Inc | Nashville | Tennessee | United States |
| Austin | Texas | 78745 | United States |
| Austin Gastroenterology, PA | Austin | Texas | United States |
| Baylor University Medical Center | Dallas | Texas | United States |
| Methodist Transplant Physicians | Dallas | Texas | United States |
| Galveston | Texas | United States |
| Houston | Texas | 77028 | United States |
| Advanced Liver Therapies | Houston | Texas | United States |
| Century Clinical Research, Inc. | Houston | Texas | United States |
| Brooke Army Medical Center | San Antonio | Texas | United States |
| Salt Lake City | Utah | 84121 | United States |
| Salt Lake City | Utah | United States |
| University of Virginia | Charlottesville | Virginia | United States |
| Fairfax | Virginia | 22031 | United States |
| Metropolitan Research | Fairfax | Virginia | United States |
| Richmond | Virginia | United States |
| Virginia Mason Medical Center | Seattle | Washington | United States |
| Tacoma | Washington | 98405 | United States |
| Centro De Hepatologia | Buenos Aires | Argentina |
| Funcei | Buenos Aires | Argentina |
| Fundacion Favaloro | Buenos Aires | Argentina |
| Hospital Aleman | Buenos Aires | Argentina |
| Hospital Britanico de Buenos Aires | Buenos Aires | Argentina |
| Hospital Universitario Austral | Buenos Aires | Argentina |
| Sanatorio de la Trinidad Mitre | Buenos Aires | Argentina |
| Sanatorio Guemes | Buenos Aires | Argentina |
| Sanatorio Dei Salvador | Córdoba | Argentina |
| H.I.G.A.O. Alende | Mar del Plata | Argentina |
| Concord Repatriation General Hospital | Concord | New South Wales | Australia |
| Royal Prince Alfred Hospital | Sydney | New South Wales | Australia |
| Princess Alexandra Hospital | Brisbane | Queensland | Australia |
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| St. Vincent's Health | Fitzroy | Victoria | Australia |
| Western Hospital | Footscray | Victoria | Australia |
| Royal Melbourne Hospital | Melbourne | Victoria | Australia |
| Fremantle Hospital | Fremantle | Western Australia | Australia |
| Royal Perth Hospital | Perth | Western Australia | Australia |
| Intituto A.Z. | Curitiba - PR | Paraná | Brazil |
| University of Rio de Janeiro Medical School Gaffree e Guinie University Hospital | Rio de Janeiro | Rio de Janeiro | Brazil |
| Hospital de Clinicas De Porto Alegre - UFRGS | Porte Alegro | Rio Grande do Sul | Brazil |
| PUC-Campinas | Campinas | São Paulo | Brazil |
| School of Medicine of Ribeirao Preto-University of Sao Paulo | Ribeirão Preto | São Paulo | Brazil |
| Facuidade de Medicina do ABC | Santo André | São Paulo | Brazil |
| Instituto de Ciencias do Hospital Alemao Oswaldo Cruz and Centro de Hepatologia de Sao Paulo | São Paulo | São Paulo | Brazil |
| Instituto de Infectologia Emilio Ribas | São Paulo | São Paulo | Brazil |
| Universidade Federal de Sao Paulo | São Paulo | São Paulo | Brazil |
| NICI Infectologia | Sorocaba | São Paulo | Brazil |
| Santa Casa De Belo Horizonte | Belo Horizonte | Brazil |
| University of Calgary | Calgary | Alberta | Canada |
| Liver and Intestinal Research Centre (LAIR Centre) | Vancouver | British Columbia | Canada |
| UBC/Downtown ID Clinic | Vancouver | British Columbia | Canada |
| Vancouver | British Columbia | Canada |
| Halifax | Nova Scotia | Canada |
| St. Joseph's Healthcare | Hamilton | Ontario | Canada |
| London | Ontario | Canada |
| Ottawa | Ontario | Canada |
| Toronto | Ontario | Canada |
| The University of Hong Kong | Pok Fu Lam | Hong Kong | China |
| The Chinese University of Hong Kong | Shatin | Hong Kong | China |
| Alice Ho Miu Ling Nethersole Hospital | Tai Po | Hong Kong | China |
| Agios Savvas Hospital | Athens | Greece |
| Ippokration General Hospital | Athens | Greece |
| Laiko General Hospital | Athens | Greece |
| Santurce | 00909 | Puerto Rico |
| Fundacion de Investigacion de Diego | Santurce | Puerto Rico |
| Hospital General Universitario de Alicant | Alicante | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | Spain |
| Hospital Vall D'Hebron | Barcelona | Spain |
| Hospital Clinico San Carlos | Madrid | Spain |
| Hospital Universitario de La Princesa | Madrid | Spain |
| Hospital Universitario La Paz | Madrid | Spain |
| Hospital Universitario Puerta de Hierro | Madrid | Spain |
| Chang Gung Memorial Hospital Kaosiung | Kaohsiung City | Taiwan |
| Chung-Ho Memorial Hospital, Kaohsiung Medical University Hospital | Kaohsiung City | Taiwan |
| Taichung Veterans General Hospital | Taichung | Taiwan |
| National Cheng Kung University Hospital | Tainan | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| Naresuan University | Phitsanulok | Changwat Phitsanulok | Thailand |
| NKC Institute of Gastroenterology and Hepatology/Songklanagarind Hospital | Hat Yai | Changwat Songkhla | Thailand |
| Phramongkutklao Hospital | Bangkok | Thailand |
| Siriraj Hosptial, Mahidol University | Bangkok | Thailand |
| Chang Mai University | Chiang Mai | Thailand |
| Srinagarind Hospital, Khon Kaen University | Khon Kaen | Thailand |
| Gartnavel General Hospital | Glasgow | United Kingdom |
| St. George's NHS Trust | London | United Kingdom |
| ID | Term |
|---|---|
| D006521 | Hepatitis, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| C034935 | clevudine |
| C053001 | adefovir |
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