A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
A Phase II, Randomized, Partially-Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of 12 Weeks of Treatment with Clevudine (10 mg, 30 mg or 50 mg QD) in Patients Infected with Hepatitis B Virus.
1 other identifier
interventional
30
5 countries
11
Brief Summary
The purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis B virus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
August 20, 2002
CompletedFirst Posted
Study publicly available on registry
August 21, 2002
CompletedJune 24, 2005
November 1, 2002
August 20, 2002
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- HBV DNA positive with DNA levels at screening greater than or equal to 3,000,000 copies/mL.
- 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.
You may not qualify if:
- Currently receiving antiviral, immunomodulatory or corticosteroid therapy
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Thomas Jefferson University Hospital, Jefferson Medical College
Philadelphia, Pennsylvania, 19107, United States
Viridae
Vancouver, V6Z1Y8, Canada
University of British Columbia, Downtown Infectious Disease Clinic
Vancouver, V6Z2C7, 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, 92118, France
Hospital Dieu, Service Hepatogastroenterologie-endoscopie
Lyon, 69288, France
Hospital St Louis, Service de Medecine Interne
Paris, 75010, France
Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie
Vandœuvre-lès-Nancy, 54511, France
National University Hospital, Division of Gastroenterology, Department of Medicine
Singapore, 119074, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 20, 2002
First Posted
August 21, 2002
Study Start
August 1, 2002
Last Updated
June 24, 2005
Record last verified: 2002-11