A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00044135
• Date of registration: 20/08/2002
• Prospective Registration: No
• Primary sponsor: Triangle Pharmaceuticals
• Public title: A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
• Scientific 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.
• Date of first enrolment: August 2002
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00044135
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada, China, France, United States

Key inclusion & exclusion 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)



Age minimum: 18 Years
Age maximum: 60 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Hepatitis B

Intervention(s)

Drug: clevudine (drug)

Secondary ID(s)

L-FMAU-102 B

Source(s) of Monetary Support

Please refer to primary and secondary sponsors