Prophylactic Use of Entecavir for HBsAg Positive Lymphoma Patients Treated With Rituximab-based Immunochemotherapy

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01768195

Enrollment

Registered

2013-01-15

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, rituximab

Brief summary

The purpose of this study is to identify the effect of prophylactic entecavir in HBsAg Positive lymphoma patients treated with rituximab-based immunochemotherapy.

Detailed description

HBsAg Positive lymphoma patients are treated with entecavir when they receive rituximab-based immunochemotherapy. Entecavir 0.5mg daily is administrated from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.

Interventions

DRUGEntecavir prophylaxis

Entecavir 0.5mg daily from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy. In patients with low load of hepatitis B virus DNA(≤2000 IU/ml), rituximab will be administrated at the beginning of entecavir prophylaxis. And in patients with high load of hepatitis B virus DNA(\>2000 IU/ml), rituximab will be administrated when hepatitis B virus DNA decreased to the level of 2000 IU/ml after entecavir prophylaxis.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* treatment-naive patients with B-cell lymphoma * HBsAg positive at baseline * treated with rituximab-based immunochemotherapy * life expectancy of more than 3 months

Exclusion criteria

* younger than 18 years old * HBsAg negative 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 immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy

Secondary

Measure	Time frame
the incidence of hepatitis B virus virological response	from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
the incidence of hepatitis B virus serological response	from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
the incidence of hepatitis B virus maintained response	from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
the incidence of hepatitis B virus sustained response	from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy
the incidence of hepatitis B virus relapse and relapse related hepatitis	from the beginning of immunochemotherapy and/or chemotherapy to 24 months after the last cycle of immunochemotherapy and/or chemotherapy

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