Clinical trial · Interventional
Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)
Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody) (REHEB):a Single Arm, Open Label, Multi-center Phase II Study
- 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)
This phase 2 trial aims to evaluate the efficacy of entecavir prophylacxis for hepatitis B virus (HBV) reactivation that continues until 6 months after completing CD20 monoclonal antibody therapy in patients with CD20-positive B-cell lymphomas and resolved hepatitis B (negative hepatitis B surface antigen, positive hepatitis B core antibody).
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 |
|---|---|---|---|
| CD20 Positive B-cell Lymphoma | — | UNRESOLVED | — |
| Resolved Hepatitis B | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Entecavir | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Entecavir prophylaxis
- description
- 0.5mg qd
- interventionNames
- Drug: Entecavir
Primary outcomes (1)
- measure
- Cumulative HBV reactivation rate
- timeFrame
- 12 months
- description
- Cumulative incidence of hepatitis B virus reactivation
Secondary outcomes (2)
- measure
- Incidence of HBV-related liver failure
- timeFrame
- 12 months
- description
- Incidence of HBV-related liver failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically confirmed CD20 positive B-cell lymphoma; * Plan to receive first-line anti-lymphoma therapy containing CD20 monoclonal antibodies; * Negative HBsAg, HBV-DNA lower than the detection limit and positive anti-HBC at baseline; * Total bilirubin less than 1.5X the upper limit of normal (ULN), AST and ALT less than 2.5X ULN; * ECOG PS: 0\~2; * Estimated survival time \>3 months. Exclusion Criteria: * Positive HBsAg or HBV-DNA higher than the detection limit at baseline; * Previous chemotherapy or radiotherapy for lymphoma; * Other primary liver diseases, such as chronic hepatitis C, hepatitis D, autoimmune hepatitis, Wilson' s disease or primary biliary cirrhosis; * Pregnant or lactating women; * History of immunodeficiency, including positive HIV, or other acquired congenital immunodeficiency disease, or history of organ transplantation.
References
Publications (0)
Data not yet available