None listed
Conditions
Interventions
Drug : In patients with chronic hepatitis B receiving tenofovir disoproxil fumarate (TDF), treatment is switched to Vemlino tablets (tenofovir alafenamide hemimaleate) or Vemlidy tablets (tenofovir al
Sponsors
Samil Pharm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female adults aged =19 years and <75 years 2) Patients with compensated liver disease (Child-Pugh score <8) 3) Patients with confirmed hepatitis B surface antigen (HBsAg) positivity for at least 6 months 4) Patients who are either hepatitis B e antigen (HBeAg) positive or negative 5) Patients receiving tenofovir disoproxil fumarate (TDF) 300 mg (equivalent to 245 mg of tenofovir disoproxil as the active moiety) as monotherapy for at least 24 weeks for chronic hepatitis B 6) Patients with confirmed virologic suppression on TDF(tenofovir disoproxil fumarate) (HBV DNA < 60 IU/mL) and who are considered to require at least 48 weeks of tenofovir alafenamide (TAF) monotherapy 7) Patients who voluntarily agree to participate in the clinical trial and provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with confirmed co-infection with other hepatitis viruses (hepatitis C or hepatitis D virus) or human immunodeficiency virus (HIV) 2) Patients with current alcohol abuse (=40 g/day) or a history of illicit drug abuse 3) Patients who have received treatment for chronic hepatitis B other than tenofovir disoproxil fumarate (TDF) within 12 months prior to screening, or who have received other immunomodulatory therapies 4) Patients meeting any of the following conditions: ? Ascites, variceal bleeding, or hepatic encephalopathy ? Child-Pugh score = 8 5) Patients requiring systemic prednisolone at a dose of =20 mg/day for more than 2 weeks, or requiring immunosuppressive agents (including anticancer chemotherapeutic agents) 6) Patients who have undergone solid organ transplantation or bone marrow transplantation 7) Patients with hypersensitivity to tenofovir alafenamide 8) Patients who have received tenofovir alafenamide within 12 weeks prior to screening 9) Patients with a history of hepatocellular carcinoma within 5 years prior to screening 10) Patients with a history of malignancy other than hepatocellular carcinoma [However, patients may be eligible if they are considered to have no evidence of disease and have not received chemotherapy or surgical treatment for the malignancy within the past 3 years, or in cases of basal cell carcinoma or squamous cell carcinoma of the skin, if deemed cured at the investigator’s discretion.] 11) Patients currently participating in another clinical trial involving investigational drug administration [However, participation is allowed if the trial does not involve antiviral agents (prohibited concomitant medications) or immunosuppressive agents.] 12) Women of childbearing potential who do not agree to use medically acceptable methods of contraception during the study period [Acceptable methods include intrauterine device (IUD) or intrauterine system (IUS), tubal ligation, or double-barrier methods (e.g., male condom, female condom, cervical cap, diaphragm, contraceptive sponge used in combination).] 13) Pregnant or breastfeeding women 14) Patients with hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 15) Any other patients deemed by the investigator to be unsuitable for participation in the clinical trial for clinical reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects maintaining HBV DNA < 60 IU/mL. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with serum HBV DNA < 60 IU/mL at baseline who achieve suppression to serum HBV DNA < 29 IU/mL at Weeks 24 and 48.;Proportion of subjects with serum HBV DNA < 29 IU/mL at baseline who maintain serum HBV DNA < 29 IU/mL at Weeks 24 and 48.;Changes in AST, ALT, and r-GTP levels at Weeks 24 and 48 compared to baseline.;Changes in insulin resistance (HOMA-IR = 2.0), HbA1c, and fasting blood glucose at Weeks 24 and 48 compared to baseline.;Changes in blood lipid levels (total cholesterol, LDL-cholesterol, HDL-cholesterol, and triglycerides) at Weeks 24 and 48 compared to baseline.;Changes in NAFLD risk factors (e.g., blood pressure, body weight) at Weeks 24 and 48 compared to baseline.;Changes in renal function at Weeks 24 and 48 compared to baseline.;Changes in bone mineral density at Weeks 24 and 48 compared to baseline.;Changes in serum phosphorus levels at Weeks 24 and 48 compared to baseline.;Discontinuation rate of study drug due to adverse events. | — |
Countries
Korea, Republic of
Contacts
Public Contactyoonjun kim
Seoul National University Hospital
Outcome results
None listed