Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

Study Overview
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Brief Summary
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The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma.

Detailed Description
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The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Negative/HBcAb Positive/hepatitis B virus DNA Negative patients with lymphoma are randomized into entecavir prophylaxis group or observation group. In entecavir prophylaxis group, entecavir 0.5 mg/day orally is initiate on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. In observation group, entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Official Title
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Prophylactic Use of Entecavir for HBsAg Negative/HBcAb Positive/Hepatitis B Virus DNA Negative Patients With Lymphoma

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Entecavir prophylaxis
* Drug: Observation arm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: treatment-naive patients with lymphoma HBsAg negative/HBcAb positive/hepatitis B virus DNA negative at baseline treated with chemotherapy and/or immunosuppressive therapy life expectancy of more than 3 months Exclusion Criteria: younger than 18 years old HBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline pregnant or lactating women

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Entecavir prophylaxis<br>Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of antitumor therapy, and will be continued until at least 6 months after completion of antitumor therapy. | Drug: Entecavir prophylaxis<br>* Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy<br>* Other names: Baraclude;|
| Active Comparator: Observation arm<br>Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation. | Drug: Observation arm<br>* Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.<br>* Other names: Therapeutic entecavir group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of hepatitis B virus reactivation and hepatitis B virus reactivation related hepatitis |  | from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of hepatitis B virus maintained response, the incidence of hepatitis B virus sustained response, the incidence of hepatitis B virus relapse and hepatitis B virus relapse related hepatitis |  | from the beginning of anti-tumor therapy to 18 months after the last cycle of anti-tumor therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Hepatitis B virus, Therapeutic Uses, Antiviral Agents