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Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB
Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
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.
Official title: Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With HBeAg-positive or HBeAg-negative Chronic Hepatitis B - a Multicenter, Open-label Follow-up Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
640
Start Date
2022-03-10
Completion Date
2029-09-30
Last Updated
2024-12-19
Healthy Volunteers
No
Conditions
Interventions
Tenofovir Amibufenamide(TMF)
Once-daily oral dose of 25 mg TMF were maintained in all participants
Locations (1)
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China