A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy

Study Overview
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Brief Summary
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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

Official Title
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A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: adefovir dipivoxil
* Drug: lamivudine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HBsAg+, nucleoside/nucleotide analogue naïve, malignant disease for iv chemotherapy Exclusion Criteria: HCV+ HDV+

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: adefovir dipivoxil|nan|
|Drug: lamivudine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the development of viral resistance to anti-viral therapy: lamivudine versus adefovir dipivoxil in immunosuppressed patients |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of adefovir dipivoxil in HBV seropositive patients who are planned to undergo chemotherapy, as compared to lamivudine. |  | 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV