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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

190

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Jan 2013

Longer than P75 for phase_4

Geographic Reach

1 country

13 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.9 years study duration

Study Start

First participant enrolled

January 1, 2013

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2013

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed

Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

4.9 years

First QC Date

January 9, 2013

Last Update Submit

January 8, 2017

Conditions

Hepatitis B

Keywords

LymphomaHepatitis B virusTherapeutic UsesAntiviral Agents

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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

Study Arms (2)

Entecavir prophylaxis

EXPERIMENTAL

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

Observation arm

ACTIVE COMPARATOR

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

Drug: Observation arm

Interventions

Entecavir prophylaxisDRUG

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

Also known as: Baraclude

Entecavir prophylaxis

Observation armDRUG

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

Also known as: Therapeutic entecavir group

Observation arm

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

younger than 18 years old
HBsAg positive or HBcAb negative or hepatitis B virus DNA positive at baseline
pregnant or lactating women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Peking Universitylead

Study Sites (13)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

307 Hospital of the Chinese People's Liberation Army