Continuing Lamivudine Versus Switching to Entecavir in Patients Who Achieved Undetectable HBV DNA

Phase 4

Completed

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Entecavir; Drug: Lamivudine

• Registration Number: NCT00625339
• Lead Sponsor: Yonsei University

Brief Summary

This is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg QD from lamivudine versus maintaining lamivudine 100mg QD treatment in CHB patients currently receiving lamivudine monotherapy.

Detailed Description

Entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of Lamivudine in nucleoside-naïve CHB patients. The switch from Lamivudine to Entecavir in patients who have undetectable hepatitis B virus DNA (HBV DNA \< 60 IU/mL) may lead to more prolonged viral suppression to undetectable level by PCR method, compared to patients with continuous lamivudine treatment. The results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from LAM to ETV.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-19
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-02-28
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-07
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic HBV infection for at least 6 months with < HBV DNA 60 IU/mL level and HBeAg positive status.

Exclusion Criteria

• Subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study.
• Subjects should have ALT < 10 x ULN, and no evidence of hepatocellular carcinoma.
• Subjects should be without serological evidence of co-infection with HCV, HIV, or HDV.
• Subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Entecavir	entecavir 0.5 mg QD
B	Lamivudine	lamivudine 100 mg QD

Primary Outcome Measures

Name	Time	Method
Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy	at Week 96

Secondary Outcome Measures

Name	Time	Method
Percentage number of patients with HBV DNA < 60 IU/mL (Undetectable serum HBV DNA by PCR method) while on randomized therapy	at Week 48
Percentage number of patients who achieved ALT normalization, HBeAg loss, HBe seroconversion, HBsAg loss and HBs seroconversion	at Week 48 and 96
Cumulative discontinuation rates due to lamivudine or entecavir resistance mutations and clinical breakthrough, Safety assessment	Follow up period

Trial Locations

Locations (2)

Pusan National University School of Medicine; 🇰🇷 Busan, Korea, Republic of

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of