Tenofovir to Prevent HBV Reactivation

Official Title

A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia

Summary:

The purpose of the study is to determine how effective preemptive tenofovir therapy is in preventing the re-activation of Hepatitis B infection, in patients who are receiving rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation will be compared between patients who receive preemptive tenofovir and patients who receive tenofovir as needed.

Trial Description

Primary Outcome:

  • Rate of reverse seroconversion
Secondary Outcome:
  • Rates of HBV Reactivation
  • Severe HBV-associated hepatitis
  • HBV-related liver failure
  • Liver-related death
  • Treatment-related adverse effects (AEs)
  • Time to start chemotherapy
  • Chemotherapy interruption
  • All-cause mortality

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society