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Trial Title:
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
NCT ID:
NCT06221657
Condition:
Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication
Conditions: Official terms:
Hepatitis A
Hepatitis B
Hematologic Neoplasms
Hepatitis
Hematologic Diseases
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Vemlidy
Description:
1 tablet once a day, oral administration
Arm group label:
TAF group
Intervention type:
Drug
Intervention name:
Virreal
Description:
1 tablet once a day, oral administration
Arm group label:
TDF group
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.
Criteria for 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.
Gender:
All
Minimum age:
19 Years
Maximum age:
65 Years
Healthy volunteers:
No
Start date:
February 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Yonsei University
Agency class:
Other
Source:
Yonsei University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06221657
