Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
- Conditions
- Chronic HepatitisHepatitis B
- Registration Number
- NCT00496158
- 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, 72 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 negative hepatitis B infection (i.e., based on serological, virological and histological markers) will be eligible for this study.
- Subjects entering the study with an historical biopsy will have chronic hepatic inflammatory injury at screening (Knodell HAI score ≥ 4 and modified Ishak fibrosis score ≤ 5).
- The number of subjects entering the study with an Ishak fibrosis score of 5 will be limited to approximately 10%. 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 (88)
Advanced Clinical Research Institution
🇺🇸Anaheim, California, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
Methodist Transplant Physicians
🇺🇸Dallas, Texas, United States
Royal Prince Alfred Hospital
🇦🇺Sydney, New South Wales, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Sharp Rees-Stealy Medical Group, Inc.
🇺🇸San Diego, California, United States
Medical Associates Research Group
🇺🇸San Diego, California, United States
Advanced Liver Therapies
🇺🇸Houston, Texas, United States
Century Clinical Research Inc
🇺🇸Houston, Texas, United States
Brooke Army Mecial Center
🇺🇸San Antonio, Texas, United States
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
Fremantle Hospital
🇦🇺Fremantle, Western Australia, Australia
NKC Institute of Gastroenterology and Hepatology/ Songklanagarind Hospital
🇹🇭Hat Yai, Songkhla, Thailand
Quest Clinical Research
🇺🇸San Francisco, California, United States
Ucsf/Sfgh
🇺🇸San Francisco, California, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Oregon Health & Science University (OHSU)
🇺🇸Portland, Oregon, United States
The Oregon Clinic P.C.
🇺🇸Portland, Oregon, United States
Nashville Gastrointestinal Specialists, Inc
🇺🇸Nashville, Tennessee, United States
San Mateo Medical Center
🇺🇸San Mateo, California, United States
Banks Hepatology Institute
🇺🇸College Park, Maryland, United States
Asheville Gastroenterology
🇺🇸Asheville, North Carolina, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
Hospital Clinico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Laiko General Hospital
🇬🇷Athens, Greece
Fundacion de Investigacion de Diego
🇵🇷Santurce, Puerto Rico
Srinagarind Hospital, Khon Kaen University
🇹🇭Khon Kaen, Thailand
Siriraj Hospital, Mahidol University
🇹🇭Bangkok, Thailand
Chiang Mai University
🇹🇭Chiang Mai, Thailand
Gartnavel General Hospital
🇬🇧Glasgow, United Kingdom
St. George's NHS Trust
🇬🇧London, United Kingdom
Metropolitan Research
🇺🇸Fairfax, Virginia, United States
West Gastroenterology Medical Group
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
The William W. Backus Hospital
🇺🇸Norwich, Connecticut, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
VAMC/NYU
🇺🇸New York, New York, United States
Digestive Health Specialists
🇺🇸Tupelo, Mississippi, United States
UMA Research Department
🇺🇸Binghamton, New York, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Funcei
🇦🇷Buenos Aires, Argentina
Centro de Hepatologia
🇦🇷Buenos Aires, Argentina
Hospital Aleman
🇦🇷Buenos Aires, Argentina
Fundacion Favaloro
🇦🇷Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
🇦🇷Buenos Aires, Argentina
Sanatorio de la Trinidad Mitre
🇦🇷Buenos Aires, Argentina
Sanatorio Guemes
🇦🇷Buenos Aires, Argentina
Hospital Universitario Austral
🇦🇷Buenos Aires, Argentina
H.I.G.A O. Alende
🇦🇷Mar del Plata, Argentina
Sanatorio Dei Salvador
🇦🇷Cordoba, Argentina
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Princess Alexandra Hospital
🇦🇺Brisbane, Queensland, Australia
Royal Brisbane and Women's Hospital
🇦🇺Brisbane, Queensland, Australia
St. Vincent's
🇦🇺Fitzroy, Victoria, Australia
Western Hospital
🇦🇺Footscray, Victoria, Australia
Royal Melbourne Hospital
🇦🇺Melbourne, Victoria, Australia
University of Calgary
🇨🇦Calgary, Alberta, Canada
Liver and Intestinal Research Center (LAIR Center)
🇨🇦Vancouver, British Columbia, Canada
UBC/ Downtown ID Clinic
🇨🇦Vancouver, British Columbia, Canada
St. Joseph's Healthcare
🇨🇦Hamilton, Ontario, Canada
Alice Ho Miu Ling Nethersole Hospital
🇨🇳Hong Kong, China
The Chinese University of Hong Kong
🇨🇳Hong Kong, China
Agios Savvas Hospital
🇬🇷Athens, Greece
The University of Hong Kong
🇨🇳Hong Kong, China
Ippokration General Hospital
🇬🇷Athens, Greece
Hospital General Universitario de Alicante
🇪🇸Alicante, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario de La Princesa
🇪🇸Madrid, Spain
Chang Gung Memorial Hospital Kaosiung
🇨🇳Kaohsiung, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Kaohsiung Medical University Hospital
🇨🇳Kaohsiung, Taiwan
Phramongkutklao Hospital
🇹🇭Bangkok, Thailand
Infectious Disease Reseach Institute, Inc
🇺🇸Tampa, Florida, United States
Hospital Universitario Puerta de Hierro
🇪🇸Madrid, Spain
Naresuan University
🇹🇭Phitsanulok, Thailand
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
California Pacific Medical Center
🇺🇸San Francisco, California, United States
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