Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

Not Applicable

Completed

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

• Registration Number: NCT01013272
• Lead Sponsor: The University of Hong Kong

Brief Summary

Patients with chronic hepatitis B and treated with entecavir for over 6 months (with no previous other antiviral treatment) will be invited to participate in this study. They will be eligible if their liver tests are normal and their viral load is undetectable. Patients will be switched to lamivudine treatment to assess whether lamivudine can maintain adequate suppression of the hepatitis B virus after successful treatment with entecavir. Patients will be monitored closely after switching treatment at 1 months and then every 3 monthly. If there is any evidence of increase in viral load then patients will be given the option of changing back to entecavir.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2009-11-12
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients with chronic hepatitis B treated with entecavir for 6 months or more
• Normal ALT
• Undetectable HBV DNA by Roche Taqman PCR Assay
• No other previous therapy with nucleoside/nucleotide analogues

Exclusion Criteria

• Presence of other liver diseases including hepatitis C co-infection, autoimmune hepatitis , primary biliary cirrhosis, primary sclerosing cholangitis, alcoholic liver disease, and Wilson's disease
• History of hepatocellular carcinoma
• History of decompensated liver disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lamivudine	Lamivudine	Switch to lamivudine 100mg daily
Entecavir	Entecavir	Ongoing entecavir 0.5mg daily

Primary Outcome Measures

Name	Time	Method
Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load	96 weeks

Secondary Outcome Measures

Name	Time	Method
Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load	96 weeks

Trial Locations

Locations (1)

The University of Hong Kong; 🇨🇳 Hong Kong, China