Tenofovir to Prevent HBV Reactivation

University Health Network, Toronto

Status and phase: Unknown; Phase 3

Conditions: Non-Hodgkin; Lymphoma; Hepatitis B

Treatments: Drug: Tenofovir disoproxil; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT02186574

JF62014

Details and patient eligibility

About

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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184 participants in 2 patient groups, including a placebo group

Pre-emptive tenofovir

Active Comparator group

Description:

Tenofovir disoproxil

Treatment:

Drug: Tenofovir disoproxil

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo Oral Tablet