Phase lV Study to Evaluate the Safety and Effectiveness of Switching Treatment From Lamivudine to Clevudine in the Chronic Hepatitis B Patients With Suboptimal Virologic Response During Lamivudine Treatment

Bukwang Pharmaceutical1 site in 1 country100 target enrollmentNovember 2007

InterventionsClevudine

Overview

A multi-center and open study to compare the safety and effectiveness of switching treatment from lamivudine to clevudine for 24 weeks.

Registry

clinicaltrials.gov

Start Date

November 2007

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Bukwang Pharmaceutical

•HBV DNA \> 2,000 copies/mL at screening
•Patients who have compensated liver disease (Child-Pugh score =\<6)
•Patients without LMV resistant mutation by RFMP assay
•Patients who have NOT experienced viral breakthrough at consecutive two measurements (at least one month apart) during lamivudine monotherapy
•Patients who can submit the written consent and comply with the claims postulated of this clinical trial

•Currently receiving antiviral except LMV or corticosteroid therapy
•Patients that previously received antiviral treatment for hepatitis B other than lamivudine in the proceeding 12 months
•Previous treatment with interferon or other immunomodulatory therapies must have ended at least 6 months preceding the study screening
•Treatment with nephrotoxic drugs, competitors of renal excretion, and/or hepatotoxic drugs within 2 months before study screening or during the study period
•Patients who is co-infected with HCV, HDV or HIV
•Serious concurrent medical conditions
•Prior organ transplantation
•Patient has creatinine clearance less than 60mL/min as estimated by the following formula:
•\[(140-age in years) (body weight \[kg\])\] / \[(72) (serum creatinine\] \[mg/dL\])\[Note: multiply estimates by 0.85 for women\]