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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01765231

Enrollment

190

Registered

2013-01-10

Start date

2013-01-31

Completion date

2017-12-31

Last updated

2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

Keywords

Lymphoma, Hepatitis B virus, Therapeutic Uses, Antiviral Agents

Brief summary

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

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.

Interventions

DRUGEntecavir prophylaxis

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

DRUGObservation arm

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

China

Contacts

Primary ContactJun Zhu

zj@bjcancer.org

Backup ContactYuqin Song

songyuqin622@sina.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026