his clinical trial was conducted to determine the non-inferiority and safety of prophylactic antiviral treatment of Tenofovir alafenamide (TAF) compared to Tenofovir disoproxil fumarate (TDF) in patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment. Confirm. In the case of TAF, domestic evidence when used as a first-line treatment is insufficient, so in this clinical trial, the virus suppression effect compared to TDF during the first administration of TAF to patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment was investigated. We aim to secure non-inferiority and additionally confirm the safety of TAF's known advantages of reducing renal function damage and protecting bone function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
100
1 tablet once a day, oral administration
1 tablet once a day, oral administration
Proportion of subjects maintained at HBV DNA <29 IU/mL
Time frame: 48 weeks
Proportion of subjects maintaining HBV DNA <29 IU/mL
Time frame: 72 weeks
Proportion of subjects with serum HBV DNA <60 IU/mL
Time frame: 12, 24, 48, 72 weeks
Proportion of subjects maintaining HBV DNA <10 IU/mL
Time frame: 12, 24, 48, 72 weeks
Level of AST, ALT, r-GTP
Time frame: 12, 24, 48, 72 weeks
total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride
Time frame: 12, 24, 48, 72 weeks
level of e-GFR
Time frame: 12, 24, 48, 72 weeks
creatinine clearance rate
Time frame: 12, 24, 48, 72 weeks
BMD T Score
Time frame: 24, 48, 72 weeks
blood Phosphorus levels
Time frame: 12, 24, 48, 72 weeks
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