drugset
drugset / Trial / NCT06221657

Clinical Trial for Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment

NCT06221657 ↗

Phase 4 Not yet recruiting 100 enrolled Yonsei University
RandomizedParallel-groupOpen-labelPrevention

Summary

his clinical trial was conducted to determine the non-inferiority and safety of prophylactic antiviral treatment of Tenofovir alafenamide (TAF) compared to Tenofovir disoproxil fumarate (TDF) in patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment. Confirm. In the case of TAF, domestic evidence when used as a first-line treatment is insufficient, so in this clinical trial, the virus suppression effect compared to TDF during the first administration of TAF to patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment was investigated. We aim to secure non-inferiority and additionally confirm the safety of TAF's known advantages of reducing renal function damage and protecting bone function.

Timeline

Start
2024-02-01
Primary completion
2026-12-01
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Virreal Unknown — Oral
Subject tenofovir alafenamide Small molecule — Oral

Indications

No indication recorded.