- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00489151
A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy
Liver diseases due to hepatitis B reactivation are serious causes of morbidity and mortality in hepatitis B infected patients treated with chemotherapy. We have previously shown that with pre-emptive use of lamivudine, one can drastically reduce liver-related morbidity and mortality in such patients. However, due to the development of hepatitis B virus resistance to lamivudine, some of these hepatitis B infected patients still develop hepatitis. This is a research study aiming to compare the use of adefovir dipivoxil to lamivudine in hepatitis B infected patients treated with chemotherapy. Both of these drugs have been approved for the treatment of the hepatitis B infection in the United States, European Union and Hong Kong.
All patients who were recruited in this study will receive study medication, either lamivudine 100 mg daily or adefovir dipivoxil 10 mg daily to cover the entire period of chemotherapy for 72 weeks. All patients will be follow-up for an additional 24 weeks thereafter. Altogether, 70 subjects will be recruited from Queen Mary Hospital, Hong Kong SAR.
This is an open-label study, which means that the patients and the study doctor will know which treatment the subjects are assigned into. If a subject decides to take part in the study and is found eligible, he/she will be randomly (like flipping of coin) assigned to one of the following dose groups:
Lamivudine (100 mg) tablet Adefovir dipivoxil (10 mg) tablet
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chee-Kin Hui, Dr
- Phone Number: (852) 2818 4300
- Email: ckh23@hku.hk
Study Locations
-
-
-
Hong Kong, China
- Recruiting
- Queen Mary Hospital
-
Sub-Investigator:
- Raymond Liang, Prof
-
Sub-Investigator:
- Yok-Lam Kwong, Prof
-
Sub-Investigator:
- Wing-Yan Au, Dr
-
Sub-Investigator:
- Chor-sang Chim, Dr
-
Sub-Investigator:
- Louis Chow, Dr
-
Sub-Investigator:
- Chee-Kin Hui, Dr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- HBsAg+, nucleoside/nucleotide analogue naïve, malignant disease for iv chemotherapy
Exclusion Criteria:
- HCV+ HDV+
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare the development of viral resistance to anti-viral therapy: lamivudine versus adefovir dipivoxil in immunosuppressed patients
Time Frame: 72 weeks
|
72 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess the safety of adefovir dipivoxil in HBV seropositive patients who are planned to undergo chemotherapy, as compared to lamivudine.
Time Frame: 72 weeks
|
72 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: George Lau, Dr, Department of Medicine, Queen Mary Hospital
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Hepatitis B
- 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
- Lamivudine
- Adefovir
- Adefovir dipivoxil
Other Study ID Numbers
- UW 04-315 T/637
- HARECCTR0500002
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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