- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02186574
Tenofovir to Prevent HBV Reactivation
December 10, 2019 updated by: University Health Network, Toronto
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
184
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jordan Feld, MD
- Phone Number: 416-340-4584
- Email: jordan.feld@uhn.ca
Study Contact Backup
- Name: Jamuna Nanthakumar, CCRP
- Phone Number: 6453 416-340-4800
- Email: jnanthak@uhnresearch.ca
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- Princess Margaret Cancer Centre
-
Contact:
- Nimisha Dave, BSc
- Phone Number: 4753 416-946-4501
- Email: nimisha.dave@uhn.ca
-
Contact:
- Ruth Turner, RN
- Phone Number: 416-946-2987
- Email: ruth.turner@uhn.ca
-
Principal Investigator:
- Michael Crump, MD
-
Toronto, Ontario, Canada, M5G 2C4
- Active, not recruiting
- Toronto General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Other Names:
|
Active Comparator: Pre-emptive tenofovir
Tenofovir disoproxil
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months post-chemotherapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rates of HBV Reactivation
Time Frame: 12 months post-chemotherapy
|
12 months post-chemotherapy
|
Severe HBV-associated hepatitis
Time Frame: 12 months post-chemotherapy
|
12 months post-chemotherapy
|
HBV-related liver failure
Time Frame: 12 months post-chemotherapy
|
12 months post-chemotherapy
|
Liver-related death
Time Frame: 12 months post-chemotherapy
|
12 months post-chemotherapy
|
Treatment-related adverse effects (AEs)
Time Frame: 12 months post-chemotherapy
|
12 months post-chemotherapy
|
Time to start chemotherapy
Time Frame: 12 months post-chemotherapy
|
12 months post-chemotherapy
|
Chemotherapy interruption
Time Frame: 12 months post-chemotherapy
|
12 months post-chemotherapy
|
All-cause mortality
Time Frame: 12 months post-chemotherapy
|
12 months post-chemotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Harry Janssen, MD, University Health Network, Toronto
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2015
Primary Completion (Anticipated)
February 1, 2021
Study Completion (Anticipated)
February 1, 2021
Study Registration Dates
First Submitted
July 7, 2014
First Submitted That Met QC Criteria
July 7, 2014
First Posted (Estimate)
July 10, 2014
Study Record Updates
Last Update Posted (Actual)
December 12, 2019
Last Update Submitted That Met QC Criteria
December 10, 2019
Last Verified
December 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Lymphoma
- Hepatitis B
- Hepatitis
- Hepatitis A
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Tenofovir
Other Study ID Numbers
- JF62014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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