Tenofovir to Prevent HBV Reactivation

• Status: Recruiting
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Tenofovir

Criteria

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