Clinical trial · Interventional
Tenofovir to Prevent HBV Reactivation
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Non-Hodgkin | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
| Tenofovir disoproxil | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pre-emptive tenofovir
- description
- Tenofovir disoproxil
- interventionNames
- Drug: Tenofovir disoproxil
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo Oral Tablet
Primary outcomes (1)
- measure
- Rate of reverse seroconversion
- timeFrame
- 12 months post-chemotherapy
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTabataba Vakili S, Hirode G, Zahoor A, Saunthar A, Feld JB, Hansen BE, Syeda A, Janssen HLA, Kukreti V, Kuruvilla J, Prica A, Cheung M, Buckstein R, Hicks L, Coffin CS, Street LE, Disperati P, Chan KK, Crump M, Feld JJ. Tenofovir alafenamide for prevention of HBV reactivation in HBsAg-negative, anti-HBc-positive patients undergoing rituximab-based chemotherapy: A multicenter randomized controlled trial. Hepatol Commun. 2025 Dec 3;9(12):e0859. doi: 10.1097/HC9.0000000000000859. eCollection 2025 Dec 1. PMID 41335575