Clinical trial · Interventional
TAF to Prevent HBV Reactivation in Cancer Patients
The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy
- 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)
Tenofovir alafenamide (TAF) has been approved to prevent HBV reactivation for HBsAg-positive cancer patients receiving chemotherapy. However, the real-world effectiveness and safety of TAF for cancer patients was lacing. Therefore, we conduct a prospective single arm study to evaluate the efficacy and safety of TAF as a prophylactic antiviral agent for HBsAg-positive cancer patients receiving chemotherapy.
Conditions
Conditions (1)
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 | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tenofovir alafenamide | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TAF prophylaxis
- description
- Using TAF to prevent HBV reactivation for HBsAg-positive cancer patients
- interventionNames
- Drug: Tenofovir alafenamide
Primary outcomes (1)
- measure
- The rate of HBV reactivation during TAF prophylaxis
- timeFrame
- after 48 weeks of TAF use
- description
- Definition of HBV reactivation : 1. HBV DNA increase 2 log (100-fold) compared to the baseline level 2. HBV DNA 3 log (1,000) IU/mL in a patient with previously undetectable level 3. HBV DNA 4 log (10,000) IU/mL if the baseline level is not available
Secondary outcomes (1)
- measure
- The dynamic change of eGFR during TAF prophylaxis
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (age ≥20) with positive HBsAg who are prepared to receive systemic chemotherapy * The presence of HBs antigen should be confirmed within recent two years * The patients who could receive systemic chemotherapy in 4 weeks Exclusion Criteria: * Patients with poor performance status (Zubrod-ECOG ≥ 2 or Karnofsky score ≤ 70) * Patients with cirrhosis * Patients had eGFR lower than 15 ml/min/1.73m2 and didn't receive dialysis * Patients had exposure to any NUC or interferon within 6 months before chemotherapy * Patients were co-infected with HCV or HIV * Allergy history to any tenofovir-based medication * Pregnant woman * Unable to sign inform consent
References
Publications (0)
Data not yet available