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

Completed

• Conditions: Hepatitis; Lymphoma; Hematologic Diseases; Hepatitis B

• Registration Number: NCT02108444
• Lead Sponsor: Peking University

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.

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2013-12
• Study Completion: 2014-03
• Study First Submitted: 2014-03-30
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-09
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-22
• Last Update Posted: 2014-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China