Switching Study From Lamivudine to Clevudine in the Chronic Hepatitis B Patients

Phase 4

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Clevudine

• Registration Number: NCT00558493
• Lead Sponsor: Bukwang Pharmaceutical

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2007-11-14
• Study First Submitted QC: 2007-11-14
• Study First Posted: 2007-11-15
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-24
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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]

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Clevudine	switching treatment from lamivudine to clevudine

Trial Locations

Locations (1)

Youngnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of