Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients

Hepatitis B Virus Reactivation After Withdrawal of Prophylactic Antiviral Therapy in Lymphoma Patients With Hepatitis B Virus Infection

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02108444

Enrollment

107

Registered

2014-04-09

Start date

2007-01-31

Completion date

2014-03-31

Last updated

2014-07-24

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

Conditions

Hematologic Diseases, Hepatitis, Hepatitis B, Lymphoma

Keywords

hepatitis, hepatitis B, lymphoma, Hematologic Diseases

Brief summary

This study is a retrospective analysis to explore the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the efficacy and safety of chemotherapy, and overall survival rate in lymphoma patients with hepatitis B virus infection.

Detailed description

All eligible patients received prophylactic antiviral therapy during and within 6 months after chemotherapy in previous sudy. We did not assign specific interventions to the subjects in this study. The primary endpoint of this study is the incidence of hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy. The secondary endpoints include the incidence of hepatitis flare related to hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy, the tumor response rate, and overall survival rate.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* treatment-naive patients with lymphoma * patients with a history of previous exposure to hepatitis B virus (HBV): HBsAg or hepatitis B core antibody (anti-HBc) positive

Exclusion criteria

* HBsAg and HBcAb negative

Design outcomes

Primary

Measure	Time frame	Description
the incidence of hepatitis B virus delayed reactivation	within one year after withdrawal of prophylactic antiviral therapy	hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy

Secondary

Measure	Time frame	Description
the incidence of hepatitis B virus related hepatitis flare	within one year after withdrawal of prophylactic antiviral therapy	the incidence of hepatitis B virus related hepatitis flare after withdrawal of prophylactic antiviral therapy
Number of patients that achieve a tumor response	within one year after withdrawal of prophylactic antiviral therapy	—
overall survival rate	within one year after withdrawal of prophylactic antiviral therapy	—

Countries

China

Outcome results