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Tenofovir to Prevent HBV Reactivation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02186574
Recruitment Status : Recruiting
First Posted : July 10, 2014
Last Update Posted : October 1, 2018
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Lymphoma Non-Hodgkin Drug: Tenofovir disoproxil Drug: Placebo Oral Tablet Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
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
Study Start Date : May 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Active Comparator: Pre-emptive tenofovir
Tenofovir disoproxil
Drug: Tenofovir disoproxil
Other Name: Viread

Placebo Comparator: Placebo
Drug: Placebo Oral Tablet
Other Name: Placebo

Primary Outcome Measures :
  1. 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 :
  1. Rates of HBV Reactivation [ Time Frame: 12 months post-chemotherapy ]
  2. Severe HBV-associated hepatitis [ Time Frame: 12 months post-chemotherapy ]
  3. HBV-related liver failure [ Time Frame: 12 months post-chemotherapy ]
  4. Liver-related death [ Time Frame: 12 months post-chemotherapy ]
  5. Treatment-related adverse effects (AEs) [ Time Frame: 12 months post-chemotherapy ]
  6. Time to start chemotherapy [ Time Frame: 12 months post-chemotherapy ]
  7. Chemotherapy interruption [ Time Frame: 12 months post-chemotherapy ]
  8. All-cause mortality [ Time Frame: 12 months post-chemotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02186574

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Contact: Jordan Feld, MD 416-340-4584
Contact: Jamuna Nanthakumar, CCRP 416-340-4800 ext 6453

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Canada, Ontario
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   
Contact: Ruth Turner, RN    416-946-2987   
Principal Investigator: Michael Crump, MD         
Sponsors and Collaborators
University Health Network, Toronto
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Study Director: Harry Janssen, MD University Health Network, Toronto

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Responsible Party: University Health Network, Toronto Identifier: NCT02186574     History of Changes
Other Study ID Numbers: JF62014
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Keywords provided by University Health Network, Toronto:
Hepatitis B
Additional relevant MeSH terms:
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Hepatitis B
Hepatitis A
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents