Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication
Conditions
Brief summary
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.
Interventions
DRUGVirreal
1 tablet once a day, oral administration
DRUGVemlidy
1 tablet once a day, oral administration
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adult men and women over 19 years of age and under 65 years of age 2. Patients who meet the following criteria A or B A. Those scheduled for hematopoietic stem cell transplantation and treatment with immunosuppressants or chemotherapy. B. Those scheduled to receive anticancer treatment including rituximab 3. HBcAb positive patient 4. Patients who voluntarily agreed to participate in this clinical trial and signed a written consent form
Exclusion criteria
1. Patients taking oral chronic hepatitis B antiviral drugs before starting the study 2. Galactose intolerance. Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption 3. Patients with hypersensitivity to tenofovir alafenamide citrate or tenofovir disoproxil orotate 4. Patients with abnormal renal function (e-GFR less than 15mL/min) or end-stage renal disease requiring dialysis 5. Hepatitis C patients 6. HIV-infected patients 7. Pregnant women, lactating women, or patients planning to become pregnant 8. If you are participating in another clinical trial administering medication 9. Patients who do not agree to participate in this clinical trial 10. Adults with impaired consent capacity who are unable to give consent on their own 11. Those who have taken other clinical trial drugs for less than 24 weeks 12. Other clinically determined by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects maintained at HBV DNA <29 IU/mL | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with serum HBV DNA <60 IU/mL | 12, 24, 48, 72 weeks |
| Proportion of subjects maintaining HBV DNA <10 IU/mL | 12, 24, 48, 72 weeks |
| Level of AST, ALT, r-GTP | 12, 24, 48, 72 weeks |
| total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride | 12, 24, 48, 72 weeks |
| Proportion of subjects maintaining HBV DNA <29 IU/mL | 72 weeks |
| creatinine clearance rate | 12, 24, 48, 72 weeks |
| BMD T Score | 24, 48, 72 weeks |
| blood Phosphorus levels | 12, 24, 48, 72 weeks |
| level of e-GFR | 12, 24, 48, 72 weeks |
Outcome results
None listed