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.

Condition	Treatment or Intervention	Phase
Hepatitis B	Drug: clevudine (drug)	Phase II

Further Study Details: 

Expected Total Enrollment:  30

Ages Eligible for Study:  18 Years   -   60 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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)

Illinois
      University of Illinois at Chicago, Chicago,  Illinois,  60612,  United States
Pennsylvania
      Thomas Jefferson University Hospital, Jefferson Medical College, Philadelphia,  Pennsylvania,  19107,  United States

      National University Hospital, Division of Gastroenterology, Department of Medicine, Singapore,  119074, 
Canada
      Viridae, Vancouver,  V6Z1Y8,  Canada
      University of British Columbia, Downtown Infectious Disease Clinic, Vancouver,  V6Z2C7,  Canada
China
      The University of Hong Kong, Clinical Trials Centre, Faculty of Medicine, Queen Mary Hospital, Hong Kong,  China
      Prince of Wales Hospital, Department of Medicine and Therapeutics, Hong Kong,  China
France
      Hospital St Louis, Service de Medecine Interne, Paris,  75010,  France
      Hospital Beaujon, Service Hepatologie Centre Pierre Abrami, Clichy,  92118,  France
      Hospital Dieu, Service Hepatogastroenterologie-endoscopie, Lyon,  69288,  France
      Hospital de Brabois Chu de Nancy, Service d'Hepato-gastroenterologie, Vandoeuvre,  54511,  France

Study ID Numbers:  L-FMAU-102 B
Record last reviewed:  November 2002
Last Updated:  November 20, 2002
Record first received:  August 20, 2002
ClinicalTrials.gov Identifier:  NCT00044135
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08