Tenofovir to Prevent HBV Reactivation

Study Overview
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Brief Summary
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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.

Official Title
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A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia

Conditions
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Lymphoma, Non-Hodgkin, Hepatitis B

Intervention / Treatment
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* Drug: Tenofovir disoproxil
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy HBsAg negative, anti-HBc positive Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pre-emptive tenofovir<br>Tenofovir disoproxil | Drug: Tenofovir disoproxil<br> <br> * Other names: Viread;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo Oral Tablet<br> <br> * Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reverse seroconversion | 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. | 12 months post-chemotherapy | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Hodgkin, Lymphoma, Hepatitis B, Tenofovir, Viread