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

July 22, 2014 updated by: Jun Zhu, Peking University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Peking University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
group with HBV reactivation
group with hepatitis B virus reactivation
group without HBV reactivation
group without hepatitis B virus reactivation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Investigators

  • Study Chair: Jun Zhu, MD., Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

March 30, 2014

First Submitted That Met QC Criteria

April 8, 2014

First Posted (Estimate)

April 9, 2014

Study Record Updates

Last Update Posted (Estimate)

July 24, 2014

Last Update Submitted That Met QC Criteria

July 22, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PKU 2013-Autonomous-9

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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