A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
This trial is active, not recruiting.
|Start date||August 2002|
|Trial size||30 participants|
|Trial identifier||NCT00044135, L-FMAU-102 B|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Chicago, IL||University of Illinois at Chicago||no longer recruiting|
|Philadelphia, PA||Thomas Jefferson University Hospital, Jefferson Medical College||no longer recruiting|
|Vancouver, Canada||University of British Columbia, Downtown Infectious Disease Clinic||no longer recruiting|
|Vancouver, Canada||Viridae||no longer recruiting|
|Hong Kong, China||The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital||no longer recruiting|
|Hong Kong, China||Prince of Wales Hospital, Department of Medicine and Therapeutics||no longer recruiting|
|Clichy, France||Hospital Beaujon, Service Hepatologie Centre Pierre Abrami||no longer recruiting|
|Lyon, France||Hospital Dieu, Service Hepatogastroenterologie-endoscopie||no longer recruiting|
|Paris, France||Hospital St Louis, Service de Medecine Interne||no longer recruiting|
|Vandoeuvre, France||Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie||no longer recruiting|
|,||National University Hospital, Division of Gastroenterology, Department of Medicine||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Male or female participants from 18 years up to 60 years old.
- 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.
- 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)
|Official title||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.|
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