Status:
UNKNOWN
Tenofovir to Prevent HBV Reactivation
Lead Sponsor:
University Health Network, Toronto
Conditions:
Hepatitis B
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 chemother...
Eligibility Criteria
Inclusion
- ≥ 18 years of age
- Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy
- HBsAg negative, anti-HBc positive
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT02186574
Start Date
May 1 2015
End Date
February 1 2021
Last Update
December 12 2019
Active Locations (2)
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1
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9