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Active, not recruiting Phase 4

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

NCT06743438 · tracked via the Priya Life Science China tracker
Phase
Phase 4
Started
2022-03-10
Last updated
2024-12-19

Condition(s) studied

Hepatitis B, Chronic

Investigational drug(s) / intervention(s)

Tenofovir Amibufenamide(TMF) →

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with HBeAg-positive or HBeAg-negative chronic hepatitis B who completed a pivotal Phase III clinical study of HS-10234-301 Exclusion Criteria: * 1\) Completion of HS-10234-301 pivotal Phase III clinical study Interruption of TMF treatment for more than 24 weeks or continuous use of alternative, commercially available hepatitis B antivirals for more than 24 weeks (Participants who have discontinued TMF for more than 24 weeks can only be enrolled in this study after investigator evaluation and confirmation) 2)Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging). 3)significant bone disease (e.g. osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures. 4)Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion. 5)Known hypersensitivity to study drugs, metabolites, or formulation excipients. 6\) In the investigator's judgment, current alcohol or substance abuse may interfere with the subject's compliance with the study requirements 7)Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.

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)

FacilityCityRegionStatus
Nanfang Hospital, Southern Medical University Guangzhou Guangdong
Official registry record

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