Clinical trial NCT06221657: Clinical Trial for Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment
Official title: A Single-center, Prospective, Randomized, Open-label, Comparative, Investigator-initiated Clinical Trial to Confirm the Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-01-24
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of subjects maintained at HBV DNA <29 IU/mL
timeFrame: 48 weeks
Secondary outcomes:
measure: Proportion of subjects maintaining HBV DNA <29 IU/mL
timeFrame: 72 weeks
measure: Proportion of subjects with serum HBV DNA <60 IU/mL
timeFrame: 12, 24, 48, 72 weeks
measure: Proportion of subjects maintaining HBV DNA <10 IU/mL
timeFrame: 12, 24, 48, 72 weeks
measure: Level of AST, ALT, r-GTP
timeFrame: 12, 24, 48, 72 weeks
measure: total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride
timeFrame: 12, 24, 48, 72 weeks
measure: level of e-GFR
timeFrame: 12, 24, 48, 72 weeks
measure: creatinine clearance rate
timeFrame: 12, 24, 48, 72 weeks
measure: BMD T Score
timeFrame: 24, 48, 72 weeks
measure: blood Phosphorus levels
timeFrame: 12, 24, 48, 72 weeks
Other outcomes:
Locations:
Study officials:
References: