Efficacy and Safety of Clevudine Compared With Adefovir in Patients With HBeAg Positive Chronic Hepatitis Due to Hepatitis B Virus
NCT ID: NCT00496002
Last Updated: 2009-04-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
INTERVENTIONAL
2007-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Clevudine Compared With Adefovir in Patients With Chronic Hepatitis Due to Hepatitis B Virus
NCT00496158
A Double-Blind Randomized Clinical Trial Comparing the Safety and Antiviral Activity of 48-week Clevudine and Adefovir Dipivoxil in HBeAg(-) Chronic Hepatitis B With Compensated Liver Function
NCT00641082
ANRS HB 05 Multicenter Study Evaluating Efficacy and Safety of Clevudine Monotherapy Versus Tenofovir Monotherapy Versus Combination Therapy of Clevudine and Tenofovir for 96 Weeks in HBeAg Negative Patients With Chronic Hepatitis B, naïve to Anti-VHB Therapy
NCT00823342
Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients
NCT00798460
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
NCT00044135
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Clevudine
Adefovir
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* Subjects with clinically significant concomitant diseases will be excluded.
16 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pharmasset
INDUSTRY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
M. Michelle Berrey, MD, MPH
Role: STUDY_DIRECTOR
Pharmasset
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama Birmingham
Birmingham, Alabama, United States
Anaheim, California, United States
Advanced Clinical Research Institution
Anaheim, California, United States
Fresno, California, United States
Fresno, California, United States
Los Angeles, California, 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, 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, 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, United States
The William W. Backus Hospital
Norwich, Connecticut, United States
Tampa, Florida, 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, 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, United States
Asheville Gastroenterology
Asheville, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, 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, 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, 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, United States
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Fairfax, Virginia, United States
Metropolitan Research
Fairfax, Virginia, United States
Richmond, Virginia, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Tacoma, Washington, 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, , 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 City, , 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
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CI-PSI-5268-06-305
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.