Tenofovir to Prevent HBV Reactivation

December 10, 2019 updated by: University Health Network, Toronto

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

184

Phase

  • Phase 3

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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Crump, MD
      • Toronto, Ontario, Canada, M5G 2C4
        • Active, not recruiting
        • Toronto General 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ≥ 18 years of age
  2. Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
  3. HBsAg negative, anti-HBc positive

Exclusion Criteria:

  1. Current therapy with known activity against HBV
  2. Screening ALT > 10 x ULN
  3. Screening ALT >2 and <10 xULN with HBV DNA > 2000 IU/mL (indicates active HBV infection despite HBsAg negative and require antiviral therapy)
  4. Life expectancy < 3 months
  5. HBsAg positive
  6. HIV co-infection
  7. Active HCV co-infection (HCV RNA positive)
  8. Creatinine clearance <50 mL/min
  9. Intolerance to tenofovir
  10. Women of child-bearing potential unwilling to take contraception during the study period

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo Oral Tablet
Other Names:
  • Placebo
Active Comparator: Pre-emptive tenofovir
Tenofovir disoproxil
Drug: Tenofovir disoproxil
Other Names:
  • Viread

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of reverse seroconversion
Time Frame: 12 months post-chemotherapy
The difference in the rate of reverse seroconversion or Hepatitis B (HBV)-associated hepatitis (definition: appearance of HBsAg in the serum with or without detectable HBV DNA in a patient who was previously HBsAg-/cAb+.) between the intervention and placebo groups.
12 months post-chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Rates of HBV Reactivation
Time Frame: 12 months post-chemotherapy
12 months post-chemotherapy
Severe HBV-associated hepatitis
Time Frame: 12 months post-chemotherapy
12 months post-chemotherapy
HBV-related liver failure
Time Frame: 12 months post-chemotherapy
12 months post-chemotherapy
Liver-related death
Time Frame: 12 months post-chemotherapy
12 months post-chemotherapy
Treatment-related adverse effects (AEs)
Time Frame: 12 months post-chemotherapy
12 months post-chemotherapy
Time to start chemotherapy
Time Frame: 12 months post-chemotherapy
12 months post-chemotherapy
Chemotherapy interruption
Time Frame: 12 months post-chemotherapy
12 months post-chemotherapy
All-cause mortality
Time Frame: 12 months post-chemotherapy
12 months post-chemotherapy

Collaborators and Investigators

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

Sponsor

University Health Network, Toronto

Investigators

  • Study Director: Harry Janssen, MD, University Health Network, Toronto

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

May 1, 2015

Primary Completion (Anticipated)

February 1, 2021

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 7, 2014

First Posted (Estimate)

July 10, 2014

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JF62014

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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