A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
NCT ID: NCT00044135
Last Updated: 2005-06-24
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
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2002-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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clevudine (drug)
Eligibility Criteria
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Inclusion Criteria
* Documented to be HBsAg positive for \> 6 months OR HBsAg positive and IgM anti-HBc negative and anti-HBs negative. Patients may be HBeAg positive, and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive.
* HBeAg positive and anti-HBe negative OR HBeAg negative (pre-core mutant) and anti-HBe positive with positive HBsAg for the previous 6 months
* AST and ALT levels which are less than or equal to 10 times the upper limit of normal.
* Bilirubin levels less than or equal to 1.5 x ULN or bilirubin levels \> 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.
Exclusion Criteria
* Previous treatment with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection
* Previous treatment with interferon must have ended at least 6 months prior to screening visit
* History of ascites, variceal hemorrhage or hepatic encephalopathy
* Co-infection with HCV or HIV
* Evidence of cirrhosis or hepatocellular carcinoma (alpha fetoprotein)
18 Years
60 Years
ALL
No
Sponsors
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Triangle Pharmaceuticals
INDUSTRY
Locations
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University of Illinois at Chicago
Chicago, Illinois, United States
Thomas Jefferson University Hospital, Jefferson Medical College
Philadelphia, Pennsylvania, United States
Viridae
Vancouver, , Canada
University of British Columbia, Downtown Infectious Disease Clinic
Vancouver, , Canada
Prince of Wales Hospital, Department of Medicine and Therapeutics
Hong Kong, , China
The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital
Hong Kong, , China
Hospital Beaujon, Service Hepatologie Centre Pierre Abrami
Clichy, , France
Hospital Dieu, Service Hepatogastroenterologie-endoscopie
Lyon, , France
Hospital St Louis, Service de Medecine Interne
Paris, , France
Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie
Vandœuvre-lès-Nancy, , France
National University Hospital, Division of Gastroenterology, Department of Medicine
Singapore, , Singapore
Countries
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Other Identifiers
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L-FMAU-102 B
Identifier Type: -
Identifier Source: org_study_id