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

Triangle Pharmaceuticals

Status and phase

Unknown

Phase 2

Conditions

Hepatitis B

Treatments

Drug: clevudine (drug)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00044135

L-FMAU-102 B

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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)