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

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.

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00044135

Enrollment

Registered

2002-08-21

Start date

2002-08-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

clevudine, hepatitis B

Brief summary

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.

Interventions

DRUGclevudine (drug)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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)

Countries

Canada, China, France, Singapore, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026