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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Entecavir prophylaxis

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.

Group Type EXPERIMENTAL

Entecavir prophylaxis

Intervention Type DRUG

Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy

Observation arm

Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Group Type ACTIVE_COMPARATOR

Observation arm

Intervention Type DRUG

Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Interventions

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Entecavir prophylaxis

Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy

Intervention Type DRUG

Observation arm

Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.

Intervention Type DRUG

Other Intervention Names

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Baraclude Therapeutic entecavir group

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Jun Zhu

Peking University Cancer Hospital & Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Zhu

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

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