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Tenofovir to Prevent HBV Reactivation

Primary Purpose

Hepatitis B, Lymphoma, Non-Hodgkin

Status
Unknown status
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Tenofovir disoproxil
Placebo Oral Tablet
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B focused on measuring Non-Hodgkin, Lymphoma, Hepatitis B, Tenofovir, Viread

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toronto General Hospital
  • Princess Margaret Cancer CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pre-emptive tenofovir

Placebo

Arm Description

Tenofovir disoproxil

Placebo

Outcomes

Primary Outcome Measures

Rate of reverse seroconversion
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 7, 2014
Last Updated
December 10, 2019
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT02186574
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2021 (Anticipated)
Study Completion Date
February 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Lymphoma, Non-Hodgkin
Keywords
Non-Hodgkin, Lymphoma, Hepatitis B, Tenofovir, Viread

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pre-emptive tenofovir
Arm Type
Active Comparator
Arm Description
Tenofovir disoproxil
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tenofovir disoproxil
Other Intervention Name(s)
Viread
Intervention Type
Drug
Intervention Name(s)
Placebo Oral Tablet
Other Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Rate of reverse seroconversion
Description
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.
Time Frame
12 months post-chemotherapy
Secondary Outcome Measure Information:
Title
Rates of HBV Reactivation
Time Frame
12 months post-chemotherapy
Title
Severe HBV-associated hepatitis
Time Frame
12 months post-chemotherapy
Title
HBV-related liver failure
Time Frame
12 months post-chemotherapy
Title
Liver-related death
Time Frame
12 months post-chemotherapy
Title
Treatment-related adverse effects (AEs)
Time Frame
12 months post-chemotherapy
Title
Time to start chemotherapy
Time Frame
12 months post-chemotherapy
Title
Chemotherapy interruption
Time Frame
12 months post-chemotherapy
Title
All-cause mortality
Time Frame
12 months post-chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ≥ 18 years of age Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy HBsAg negative, anti-HBc positive Exclusion Criteria: Current therapy with known activity against HBV Screening ALT > 10 x ULN Screening ALT >2 and <10 xULN with HBV DNA > 2000 IU/mL (indicates active HBV infection despite HBsAg negative and require antiviral therapy) Life expectancy < 3 months HBsAg positive HIV co-infection Active HCV co-infection (HCV RNA positive) Creatinine clearance <50 mL/min Intolerance to tenofovir Women of child-bearing potential unwilling to take contraception during the study period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jordan Feld, MD
Phone
416-340-4584
Email
jordan.feld@uhn.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Jamuna Nanthakumar, CCRP
Phone
416-340-4800
Ext
6453
Email
jnanthak@uhnresearch.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry Janssen, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Study Director
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Individual Site Status
Active, not recruiting
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nimisha Dave, BSc
Phone
416-946-4501
Ext
4753
Email
nimisha.dave@uhn.ca
First Name & Middle Initial & Last Name & Degree
Ruth Turner, RN
Phone
416-946-2987
Email
ruth.turner@uhn.ca
First Name & Middle Initial & Last Name & Degree
Michael Crump, MD

12. IPD Sharing Statement

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Tenofovir to Prevent HBV Reactivation

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