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Trial record 140 of 361 for:    hepatitis b | Open Studies

Tenofovir to Prevent HBV Reactivation

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by University Health Network, Toronto
Information provided by (Responsible Party):
University Health Network, Toronto Identifier:
First received: July 7, 2014
Last updated: May 27, 2015
Last verified: May 2015
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. 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
Drug: Tenofovir disoproxil
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-centre Phase III Study to Evaluate Preemptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Rituximab-based Chemotherapy for Non-Hodgkin's Lymphoma

Resource links provided by NLM:

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 Primary Completion Date: June 2017 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  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 identifier: NCT02186574

Contact: Jordan Feld, MD 416-603-5914 ext 2684
Contact: Victor Lo, MASc, CCRP 416-603-5839

Canada, Ontario
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         
Toronto Western Hospital Active, not recruiting
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Study Director: Harry Janssen, MD University Health Network, Toronto
  More Information

Additional Information:
Responsible Party: University Health Network, Toronto Identifier: NCT02186574     History of Changes
Other Study ID Numbers: JF62014
Study First Received: July 7, 2014
Last Updated: May 27, 2015

Keywords provided by University Health Network, Toronto:
Hepatitis B

Additional relevant MeSH terms:
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liver Diseases
Digestive System Diseases
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 processed this record on May 22, 2017