Clinical trial · Interventional
Prophylactic Use of Entecavir for Non-Hodgkin's Lymphoma Patients With Resolved Hepatitis B
Prophylactic Use of Entecavir for Chemotherapy Associated With Hepatitis B Reactivation in HBsAg (-), Anti-HBc (+) Non-Hodgkin's Lymphoma Patients: a Randomized Controlled Trial
- 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)
Hepatitis B (HBV) reactivation and hepatitis flare induced by cytotoxic chemotherapy is common in cancer patients who have chronic HBV infection. Lymphoma patients who had previous infected by HBV but negative for HBsAg have a the risk of HBV reactivation during chemotherapy, but prophylactic antiviral treatment is not a routine by current American Association for the Study of Liver Diseases (AASLD) guideline. Prophylactic entecavir might reduce the risk of HBV reactivation in such patients.
Conditions
Conditions (2)
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 | — |
| Non Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entecavir prophylaxis | Drug | — | UNRESOLVED |
| Therapeutic entecavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Entecavir prophylaxis
- description
- Participants will initiate entecavir 0.5 mg/day orally on day 1 of the first course of chemotherapy, and will be continued until 3 months after completion of the chemotherapy.
- interventionNames
- Drug: Entecavir prophylaxis
- type
- ACTIVE_COMPARATOR
- label
- Therapeutic arm
- description
- In patients with HBV reactivation and ALT flare \> 100 U/L, entecavir 0.5mg daily will be prescribed for the cases till hepatitis remission
- interventionNames
- Drug: Therapeutic entecavir
Primary outcomes (1)
- measure
- The primary endpoint is the incidence of HBV reactivation during and within 12 months after chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * CD20 positive lymphoma * negative for HBsAg and positive for anti-HBc * age over 16 years old * alanine aminotransferase less than 2 times the upper limit of normal * bilirubin \< 2.5 mg/dL * neutrophil \> 2000/mm3 * platelet \> 100,000/mm3 * creatinine \< 1.5 mg/dL * urea nitrogen \< 25 mg/dL * Eastern Cooperative Oncology Group performance score 0 to 2 Exclusion Criteria: * Child-Pugh class B or C cirrhosis * grade 2 or greater heart failure by the NYHA classification * previous chemotherapy,radiotherapy, or concurrent glucocorticoid therapy for other reasons * other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, or Wilsons' disease
References
Publications (1)
- DERIVEDHuang YH, Hsiao LT, Hong YC, Chiou TJ, Yu YB, Gau JP, Liu CY, Yang MH, Tzeng CH, Lee PC, Lin HC, Lee SD. Randomized controlled trial of entecavir prophylaxis for rituximab-associated hepatitis B virus reactivation in patients with lymphoma and resolved hepatitis B. J Clin Oncol. 2013 Aug 1;31(22):2765-72. doi: 10.1200/JCO.2012.48.5938. Epub 2013 Jun 17. PMID 23775967