TAF to Prevent HBV Reactivation in Cancer Patients

• Status: Recruiting
• Trial end date: 2023-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiayi Christian Hospital
• Collaborators: Chi Mei Medical Hospital; Dalin Tzu Chi General Hospital; National Taiwan University Hospital, Yun-Lin Branch; St. Martin De Porress Hospital
• Treatments: Tenofovir

Criteria

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