Trial record 137 of 440 for:    hepatitis b | Open Studies

Tenofovir to Prevent HBV Reactivation

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT02186574
First received: July 7, 2014
Last updated: NA
Last verified: June 2014
History: No changes posted
  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. 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
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Severe HBV-associated hepatitis [ Time Frame: 12 months post-chemotherapy ] [ Designated as safety issue: Yes ]
  • HBV-related liver failure [ Time Frame: 12 months post-chemotherapy ] [ Designated as safety issue: Yes ]
  • Liver-related death [ Time Frame: 12 months post-chemotherapy ] [ Designated as safety issue: Yes ]
  • Treatment-related adverse effects (AEs) [ Time Frame: 12 months post-chemotherapy ] [ Designated as safety issue: Yes ]
  • Time to start chemotherapy [ Time Frame: 12 months post-chemotherapy ] [ Designated as safety issue: No ]
  • Chemotherapy interruption [ Time Frame: 12 months post-chemotherapy ] [ Designated as safety issue: No ]
  • All-cause mortality [ Time Frame: 12 months post-chemotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 184
Study Start Date: July 2014
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
  • HBsAg negative, anti-HBc (core) positive

Exclusion Criteria:

  • Current therapy with known activity against HBV
  • Life expectancy < 3 months
  • HBsAg positive
  • Hepatitis D/Hepatitis C (HDV/HCV) or HIV co-infection
  • Creatinine clearance <50 mL/min
  • Intolerance to tenofovir
  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 416-603-5914 ext 2684 jordan.feld@uhn.ca
Contact: Victor Lo, MASc, CCRP 416-603-5839 victor.lo@uhn.ca

Locations
Canada, Ontario
Toronto Western Hospital Not yet recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Victor Lo, MASc, CCRP    416-603-5839    victor.lo@uhn.ca   
Contact: Seham Noureldin, PhD    416-603-5914 ext 2523    snoureld@uhnresearch.ca   
Sub-Investigator: Harry Janssen, MD         
Sub-Investigator: David Wong, MD         
Sub-Investigator: Hemant Shah, MD         
Sub-Investigator: Joshua Juan, MD         
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Study Director: Harry Janssen, MD University Health Network, Toronto
  More Information

Additional Information:
No publications provided

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: July 7, 2014
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Non-Hodgkin
Lymphoma
Hepatitis B
Tenofovir
Viread

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Lymphoma
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014