Clinical Trials

MainTitle

Tenofovir to Prevent HBV Reactivation

This study is currently recruiting participants. (see Contacts and Locations)

Verified October 2017 by University Health Network, Toronto

Sponsor
University Health Network, Toronto


Information provided by (Responsible Party)
University Health Network, Toronto
ClinicalTrials.gov Identifier
NCT02186574

First received: July 7, 2014
Last updated: October 30, 2017
Last Verified: October 2017
History of Changes
Purpose

Purpose

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.

Condition Intervention Phase
Hepatitis B
Lymphoma
Non-Hodgkin

Drug : Tenofovir disoproxil
Drug : Placebo Oral Tablet
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures

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

Estimated Enrollment: 184
Study Start Date: May 2015
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Active Comparator: Pre-emptive tenofovir
Tenofovir disoproxil
Drug: Tenofovir disoproxil
Other Name: Viread
Placebo Comparator: Placebo
Placebo
Drug: Placebo Oral Tablet
Other Name: Placebo
Eligibility

Eligibility

Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186574

Contacts

Contact:   Jordan Feld, MD 416-340-4584 jordan.feld@uhn.ca
Contact:   Jamuna Nanthakumar, CCRP 416-340-4800 ext 6453 jnanthak@uhnresearch.ca

Locations

Canada
Toronto General Hospital Active, not recruiting
Toronto, Ontario, Canada, M5G 2C4
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Nimisha Dave, BSc    416-946-4501 ext 4753    nimisha.dave@uhn.ca
Contact: Ruth Turner, RN    416-946-2987    ruth.turner@uhn.ca
Principal Investigator: Michael Crump, MD

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Study Director: Harry Janssen, MD University Health Network, Toronto
More Information

More Information


Responsible Party: University Health Network, Toronto  
ClinicalTrials.gov Identifier: NCT02186574   History of Changes  
Other Study ID Numbers: JF62014  
Study First Received: July 7, 2014  
Last Updated: October 30, 2017  

Keywords provided by University Health Network, Toronto:

Non-Hodgkin
Lymphoma
Hepatitis B
Tenofovir
Viread

Additional relevant MeSH terms:
Lymphoma
Hepatitis
Hepatitis A
Hepatitis B
Tenofovir

ClinicalTrials.gov processed this data on December 11, 2017
This information is provided by ClinicalTrials.gov.