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

Peking University

Status and phase: Unknown; Phase 4

Conditions: Hepatitis B

Treatments: Drug: Observation arm; Drug: Entecavir prophylaxis

Study type: Interventional

Funder types: Other

Identifiers

NCT01765231

PKU-2012111305

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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190 participants in 2 patient groups

Entecavir prophylaxis

Experimental group

Description:

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.

Treatment:

Drug: Entecavir prophylaxis

Observation arm

Active Comparator group

Description:

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

Treatment:

Drug: Observation arm