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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
James Yan Yue Fung, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01013272
First received: November 12, 2009
Last updated: November 30, 2015
Last verified: November 2015
  Purpose
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.

Condition Intervention
Hepatitis B, Chronic
Drug: Entecavir
Drug: Lamivudine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load

Resource links provided by NLM:


Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load [ Time Frame: 96 weeks ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: June 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Entecavir
Ongoing entecavir 0.5mg daily
Drug: Entecavir
Entecavir 0.5mg orally daily
Other Name: Baraclude
Active Comparator: Lamivudine
Switch to lamivudine 100mg daily
Drug: Lamivudine
Lamivudine 100mg orally, daily
Other Name: Zeffix

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01013272

Locations
China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: James Fung, MBChB The University of Hong Kong
  More Information

Responsible Party: James Yan Yue Fung, Dr, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01013272     History of Changes
Other Study ID Numbers: HKUHEP-01 
Study First Received: November 12, 2009
Last Updated: November 30, 2015
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
entecavir
lamivudine
sequential therapy

Additional relevant MeSH terms:
Hepatitis B
Hepatitis B, Chronic
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Lamivudine
Entecavir
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 23, 2016