Clinical Trial

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

Active, Not Recruiting Phase 4
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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.
Trial Details
NCT Number NCT06743438
Lead Sponsor Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions Hepatitis B, Chronic
Enrollment 640 participants
Start Date 2022-03-10
Primary Completion 2024-06-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-12-19