Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB
Condition(s) studied
Investigational drug(s) / intervention(s)
Tenofovir Amibufenamide(TMF): Once-daily oral dose of 25 mg TMF were maintained in all participants
Study 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.
Eligibility
Primary outcome measure(s)
- Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory — week (144+)96
The primary efficacy endpoint was the proportion of patients with HBV DNA lower than in the central laboratory at week (144+)96.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
More Jiangsu Hansoh Pharmaceutical Co., Ltd. trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06743438 on ClinicalTrials.gov ↗ ← All trials in China