Tenofovir to Prevent HBV Reactivation

Phase 3

• Conditions: Lymphoma; Non-Hodgkin; Hepatitis B
• Interventions: Drug: Placebo Oral Tablet; Drug: Tenofovir disoproxil

• Registration Number: NCT02186574
• Lead Sponsor: University Health Network, Toronto

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-07
• Study First Posted: 2014-07-10
• Study Start: 2015-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-10
• Last Update Posted: 2019-12-12
• Primary Completion: 2021-02
• Study Completion: 2021-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 184

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Oral Tablet	Placebo
Pre-emptive tenofovir	Tenofovir disoproxil	Tenofovir disoproxil

Primary Outcome Measures

Name	Time	Method
Rate of reverse seroconversion	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.

Secondary Outcome Measures

Name	Time	Method
Liver-related death	12 months post-chemotherapy
Treatment-related adverse effects (AEs)	12 months post-chemotherapy
Severe HBV-associated hepatitis	12 months post-chemotherapy
Rates of HBV Reactivation	12 months post-chemotherapy
Chemotherapy interruption	12 months post-chemotherapy
HBV-related liver failure	12 months post-chemotherapy
All-cause mortality	12 months post-chemotherapy
Time to start chemotherapy	12 months post-chemotherapy

Trial Locations

Locations (2)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

Toronto General Hospital; 🇨🇦 Toronto, Ontario, Canada