A Phase 4 interventional study of Tenofovir Amibufenamide（TMF） in Hepatitis B, Chronic, sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd.. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment
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.
Participants from the Phase III registrational trial of TMF were enrolled and followed for another seven years, starting at week 144 in the Phase III study as the baseline. Once-daily oral dose of 25 mg TMF were maintained in all participants. Clinical assessments were conducted every 24 weeks. The primary efficacy endpoint was the percentage of patients with serum HBV DNA levels below the quantification limit at week (144+) 96.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 640 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Jiangsu Hansoh Pharmaceutical Co., Ltd. is the lead sponsor of 131 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Tenofovir Amibufenamide（TMF）
Once-daily oral dose of 25 mg TMF were maintained in all participants
Also known as: HS-10234
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory
The primary efficacy endpoint was the proportion of patients with HBV DNA lower than in the central laboratory at week (144+)96.
Time frame: week (144+)96
The proportion of subjects with HBV DNA with lower than in the central laboratory
The proportion of patients with HBV DNA lower than in the central laboratory at week(144+)240、week(144+)336
Time frame: week(144+)240、week(144+)336
Proportion of subjects with ALT normalization rate
The proportion of patients with normal ALT
Time frame: week (144+)96、week (144+)240、week (144+)336
Proportion of Patients Achieving HBsAg loss，HBsAg conversion
The denominator of HBsAg loss was the number of HBsAg- positive patients at 144 weeks. The denominator of HBsAg seroconversion was the number of HBsAg positive and anti-HBs negative persons at 144 weeks.
Time frame: week (144+)96、week (144+)240、week (144+)336
Incidence of resistance mutation
Resistance detection when a virological breakthrough occurs
Time frame: week (144+)96、week (144+)240、week (144+)336
Progression of liver disease associated with HBV infection
The proportion of patients with new HCC, Decompensated liver cirrhosis, death related to Hepatitis B
Time frame: week (144+)96、week (144+)240、week (144+)336
Proportion of Patients Achieving HBeAg loss，HBeAg conversion ratio
The denominator of HBeAg loss was the number of HBeAg- positive patients at 144 weeks. The proportion of HBeAg seroconversion was the number of HBeAg positive and anti-HBs negative persons at 144 weeks.
Time frame: week (144+)96、week (144+)240、week (144+)336
Percent Change from Baseline in Hip and spine Bone Mineral Density (BMD)
measured by dual energy x-ray absorptiometry(DXA)
Time frame: week (144+)96、week (144+)240、week (144+)336
Change from Baseline in Serum Creatinine
Time frame: week (144+)96、week (144+)240、week (144+)336
Change in HBV DNA from baseline
Time frame: week (144+)96、week (144+)240、week (144+)336
Plan to share: Undecided
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This study is active, not recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Jiangsu Hansoh Pharmaceutical Co., Ltd.