Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
184 participants
INTERVENTIONAL
2015-05-31
2021-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Pre-emptive tenofovir
Tenofovir disoproxil
Tenofovir disoproxil
Placebo
Placebo
Placebo Oral Tablet
Interventions
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Tenofovir disoproxil
Placebo Oral Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
3. HBsAg negative, anti-HBc positive
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Harry Janssen, MD
Role: STUDY_DIRECTOR
University Health Network, Toronto
Locations
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Toronto General Hospital
Toronto, Ontario, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Nimisha Dave, BSc
Role: primary
Ruth Turner, RN
Role: backup
Other Identifiers
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JF62014
Identifier Type: -
Identifier Source: org_study_id