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

NCT01013272 | Completed

• 1 other identifier: HKUHEP-01
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B, Chronic

Keywords

entecavir; lamivudine; sequential therapy

Outcome Measures

Primary Outcomes (1)

• Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load

  96 weeks

Secondary Outcomes (1)

• Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load

  96 weeks

Study Arms (2)

Entecavir

ACTIVE COMPARATOR

Ongoing entecavir 0.5mg daily

Drug: Entecavir

Lamivudine

ACTIVE COMPARATOR

Switch to lamivudine 100mg daily

Drug: Lamivudine

Interventions

Entecavir DRUG

Entecavir 0.5mg orally daily

Also known as: Baraclude

Entecavir

Lamivudine DRUG

Lamivudine 100mg orally, daily

Also known as: Zeffix

Lamivudine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir; Lamivudine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Officials

• James Fung, MBChB

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 13, 2009
• Study Start: June 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

CN (1)