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

NCT ID: NCT02108444

Last Updated: 2014-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

107 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2014-03-31

Brief Summary

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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

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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.

Conditions

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Hepatitis Hepatitis B Lymphoma Hematologic Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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group with HBV reactivation

group with hepatitis B virus reactivation

No interventions assigned to this group

group without HBV reactivation

group without hepatitis B virus reactivation

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Responsible Party

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Jun Zhu

Chairman of lymphoma department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jun Zhu, MD.

Role: STUDY_CHAIR

Peking University Cancer Hospital & Institute

Locations

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Peking University Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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PKU 2013-Autonomous-9

Identifier Type: -

Identifier Source: org_study_id

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