Clinical trial · Interventional
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Reactivation in NHL
Entecavir Versus Lamivudine for Preventing the Risk of Hepatitis B Virus Reactivation in Patients With Non-Hodgkin Lymphoma on CHOP/R-CHOP: a Randomized Phase II Study
NCT01914744CI-TRIAL-00011554unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 aim of this study is to prove the superiority of entecavir over lamivudine for preventing the risk of hepatitis B virus reactivation in patients with non-Hodgkin lymphoma on CHOP/R-CHOP.
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 Reactivation | — | UNRESOLVED | — |
| Non-Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entecavir | Drug | — | UNRESOLVED |
| Lamivudine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- entecavir
- description
- entecavir 0.5 mg/day PO
- interventionNames
- Drug: Entecavir
- Drug: Lamivudine
- type
- ACTIVE_COMPARATOR
- label
- lamivudine
- description
- lamivudine 100 mg/day PO
- interventionNames
- Drug: Entecavir
- Drug: Lamivudine
Primary outcomes (1)
- measure
- Incidence rate of HBV reactivation
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated NHL suitable for CHOP/R-CHOP treatment * Age range 18-80 years old * HBsAg positive with high level of HBV DNA * Eastern Cooperative Oncology Group performance status 0-2 * Life expectancy of more than 3 months * Adequate organ function Exclusion Criteria: * Primary or secondary central nervous system involvement * With hepatitis C virus infection * Previous serious cardiac disease * History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * Pregnant or lactating women * Serious uncontrolled diseases and intercurrent infection
References
Publications (0)
Data not yet available
No reference posted for this study.