drugset / Trial / NCT06743438

Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB

NCT06743438

Phase 4 Active not recruiting 640 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB). The previous registrational study (NCT03903796) has established the non-inferior virologic efficacy of TMF to tenofovir disoproxil fumarate (TDF), while demonstrating higher rates of alanine aminotransferase (ALT) normalization and improved bone and renal safety profiles. This study presented the long-term efficacy and safety of TMF in a phase IV study.

Timeline

Start
2022-03-10
Primary completion
2024-06-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tenofovir Amibufenamide Unknown 25 mg Oral