This trial is active, not recruiting.

Condition hepatitis b
Treatment clevudine (drug)
Phase phase 2
Sponsor Triangle Pharmaceuticals
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

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double-blind
Primary purpose treatment

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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)

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2005.
Information provided to ClinicalTrials.gov by Triangle Pharmaceuticals.