- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01013272
Lamivudine Therapy in Patients With Prior Entecavir Treatment and Undetectable Viral Load
November 30, 2015 updated by: James Yan Yue Fung, The University of Hong Kong
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Hong Kong, China
- The University of Hong Kong
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Entecavir
Ongoing entecavir 0.5mg daily
|
Entecavir 0.5mg orally daily
Other Names:
|
Active Comparator: Lamivudine
Switch to lamivudine 100mg daily
|
Lamivudine 100mg orally, daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the efficacy of lamivudine therapy in patients with prior entecavir treatment with undetectable viral load
Time Frame: 96 weeks
|
96 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine the chance of lamivudine resistance in patients with prior entecavir treatment with undetectable viral load
Time Frame: 96 weeks
|
96 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Fung, MBChB, The University of Hong Kong
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2007
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
November 12, 2009
First Submitted That Met QC Criteria
November 12, 2009
First Posted (Estimate)
November 13, 2009
Study Record Updates
Last Update Posted (Estimate)
December 2, 2015
Last Update Submitted That Met QC Criteria
November 30, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis B
- Hepatitis B, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Entecavir
- Lamivudine
Other Study ID Numbers
- HKUHEP-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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