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ACTIVE NOT RECRUITING
NCT06743438
PHASE4

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

Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

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