Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
- Conditions
- Chronic HepatitisHepatitis B
- Registration Number
- NCT00496002
- Lead Sponsor
- Pharmasset
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- Nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic HBeAg positive hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.
- Subjects with historical biopsies used for entry will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5). If applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline.
- For eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ANA titer and have a creatinine clearance of ≥ 50 mL/min.
- Subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded.
- Subjects with clinically significant concomitant diseases will be excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (99)
Asheville Gastroenterology
🇺🇸Asheville, North Carolina, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
NKC Institute of Gastroenterology and Hepatology/Songklanagarind Hospital
🇹🇭Hat Yai, Songkhla, Thailand
The William W. Backus Hospital
🇺🇸Norwich, Connecticut, United States
Banks Hepatology Institute
🇺🇸College Park, Maryland, United States
Hospital Aleman
🇦🇷Buenos Aires, Argentina
Sanatorio de la Trinidad Mitre
🇦🇷Buenos Aires, Argentina
Hospital Universitario Austral
🇦🇷Buenos Aires, Argentina
Laiko General Hospital
🇬🇷Athens, Greece
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
NICI Infectologia
🇧🇷Sorocaba, Sao Paulo, Brazil
UBC/Downtown ID Clinic
🇨🇦Vancouver, British Columbia, Canada
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
Chung-Ho Memorial Hospital, Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Srinagarind Hospital, Khon Kaen University
🇹🇭Khon Kaen, Thailand
Chang Mai University
🇹🇭Chiang Mai, Thailand
Naresuan University
🇹🇭Phitsanulok, Thailand
Century Clinical Research, Inc.
🇺🇸Houston, Texas, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Sharp Rees-Stealy Medical Group Inc
🇺🇸San Diego, California, United States
Advanced Liver Therapies
🇺🇸Houston, Texas, United States
Brooke Army Medical Center
🇺🇸San Antonio, Texas, United States
Hospital de Clinicas De Porto Alegre - UFRGS
🇧🇷Porte Alegro, Rio Grande Do Sul, Brazil
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
Weill Cornell Medical College
🇺🇸New York, New York, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Ucsf/Sfgh
🇺🇸San Francisco, California, United States
Quest Clinical Research
🇺🇸San Francisco, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Duke University
🇺🇸Durham, North Carolina, 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
San Mateo Medical Center
🇺🇸San Mateo, California, United States
Advanced Clinical Research Institution
🇺🇸Anaheim, California, United States
West Gastroenterology Medical Group
🇺🇸Los Angeles, California, United States
Methodist Transplant Physicians
🇺🇸Dallas, Texas, United States
UMA Research Department
🇺🇸Binghamton, New York, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
VAMC/NYU
🇺🇸New York, New York, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Indiana, United States
Centro De Hepatologia
🇦🇷Buenos Aires, Argentina
Fundacion Favaloro
🇦🇷Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Ippokration General Hospital
🇬🇷Athens, Greece
Chang Gung Memorial Hospital Kaosiung
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Agios Savvas Hospital
🇬🇷Athens, Greece
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital General Universitario de Alicant
🇪🇸Alicante, Spain
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Phramongkutklao Hospital
🇹🇭Bangkok, Thailand
Siriraj Hosptial, Mahidol University
🇹🇭Bangkok, Thailand
Gartnavel General Hospital
🇬🇧Glasgow, United Kingdom
St. George's NHS Trust
🇬🇧London, United Kingdom
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
Digestive Health Specialists
🇺🇸Tupelo, Mississippi, United States
Sanatorio Guemes
🇦🇷Buenos Aires, Argentina
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Funcei
🇦🇷Buenos Aires, Argentina
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
Sanatorio Dei Salvador
🇦🇷Cordoba, Argentina
H.I.G.A.O. Alende
🇦🇷Mar del Plata, Argentina
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
St. Vincent's Health
🇦🇺Fitzroy, Victoria, Australia
Western Hospital
🇦🇺Footscray, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
Intituto A.Z.
🇧🇷Curitiba - PR, PR, Brazil
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
University of Rio de Janeiro Medical School Gaffree e Guinie University Hospital
🇧🇷Rio de Janeiro, RJ, Brazil
PUC-Campinas
🇧🇷Campinas, Sao Paulo, Brazil
School of Medicine of Ribeirao Preto-University of Sao Paulo
🇧🇷Ribeirao Preto, Sao Paulo, Brazil
Facuidade de Medicina do ABC
🇧🇷Santo Andre, SP, Brazil
Universidade Federal de Sao Paulo
🇧🇷Sao Paulo, SP, Brazil
Instituto de Infectologia Emilio Ribas
🇧🇷Sao Paulo, Brazil
University of Calgary
🇨🇦Calgary, Alberta, Canada
Liver and Intestinal Research Centre (LAIR Centre)
🇨🇦Vancouver, British Columbia, Canada
Instituto de Ciencias do Hospital Alemao Oswaldo Cruz and Centro de Hepatologia de Sao Paulo
🇧🇷Sao Paulo, SP, Brazil
Santa Casa De Belo Horizonte
🇧🇷Belo Horizonte, Brazil
The Chinese University of Hong Kong
🇨🇳Shatin, Hong Kong, China
Alice Ho Miu Ling Nethersole Hospital
🇨🇳Tai Po, Hong Kong, China
St. Joseph's Healthcare
🇨🇦Hamilton, Ontario, Canada
The University of Hong Kong
🇨🇳Pok fu lam, Hong Kong, China
Infectious Disease Research Institute, Inc.
🇺🇸Tampa, Florida, United States
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Liver Center
🇺🇸Honolulu, Hawaii, United States
Iowa Health-Des Moines
🇺🇸Des Moines, Iowa, United States
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
Austin Gastroenterology, PA
🇺🇸Austin, Texas, United States