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NCT Number: NCT02108444

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

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.

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Key information

Conditions

Hepatitis Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hepadnaviridae Infections Hepatitis B Hepatitis, Viral, Human Immune System Diseases Immunoproliferative Disorders Infections Liver Diseases Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  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

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2014
First posted
Apr 9, 2014
Registry last updated
Jul 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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