Skip to main content
OpenTrials
Completed

NCT Number: NCT01013272

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Hong Kong

Hong Kong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Entecavir

Drug

Entecavir 0.5mg orally daily

Other names: Baraclude

Lamivudine

Drug

Lamivudine 100mg orally, daily

Other names: Zeffix

Primary outcomes

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

    Time frame: 96 weeks

Secondary outcomes

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

    Time frame: 96 weeks

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 13, 2009
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.