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CompletedNCT02108444Updated Jul 24, 2014

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

An observational study in Hepatitis, Hepatitis B and Lymphoma, sponsored by Peking University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-07-24.

Sponsored by Peking University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
107
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Hepatitis
  • Hepatitis B
  • Lymphoma
  • Hematologic Diseases

Keywords

  • hepatitis
  • hepatitis B
  • lymphoma
  • Hematologic Diseases
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 107 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Peking University is the lead sponsor of 411 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

lymphoma patients with hepatitis B virus infection diagnosed in Peking University Cancer Hospita

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

Exclusion Criteria:

  • HBsAg and HBcAb negative
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
107 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • group with HBV reactivation

    group with hepatitis B virus reactivation

  • group without HBV reactivation

    group without hepatitis B virus reactivation

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What researchers measure

Primary outcomes

  1. the incidence of hepatitis B virus delayed reactivation

    hepatitis B virus reactivation after withdrawal of prophylactic antiviral therapy

    Time frame: within one year after withdrawal of prophylactic antiviral therapy

Secondary outcomes

  1. the incidence of hepatitis B virus related hepatitis flare

    the incidence of hepatitis B virus related hepatitis flare after withdrawal of prophylactic antiviral therapy

    Time frame: within one year after withdrawal of prophylactic antiviral therapy

  2. Number of patients that achieve a tumor response

    Time frame: within one year after withdrawal of prophylactic antiviral therapy

  3. overall survival rate

    Time frame: within one year after withdrawal of prophylactic antiviral therapy

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Study locations

1 site
  • Peking University Cancer Hospital
    Beijing, Beijing 100142, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02108444
Lead sponsor
Peking University
Responsible party
Jun Zhu (Chairman of lymphoma department, Peking University) — Principal investigator
First posted
Apr 9, 2014
Start date
Jan 2007
Primary completion
Dec 2013
Completion
Mar 2014
Last update
Jul 24, 2014

Study contacts

Jun Zhu, MD.
study chair · Peking University Cancer Hospital & Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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