Status:
NOT_YET_RECRUITING
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
Lead Sponsor:
Yonsei University
Conditions:
Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication
Eligibility:
All Genders
19-65 years
Phase:
PHASE4
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 patie...
Eligibility Criteria
Inclusion
- Adult men and women over 19 years of age and under 65 years of age
- 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
- HBcAb positive patient
- Patients who voluntarily agreed to participate in this clinical trial and signed a written consent form
Exclusion
- Patients taking oral chronic hepatitis B antiviral drugs before starting the study
- Galactose intolerance. Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption
- Patients with hypersensitivity to tenofovir alafenamide citrate or tenofovir disoproxil orotate
- Patients with abnormal renal function (e-GFR less than 15mL/min) or end-stage renal disease requiring dialysis
- Hepatitis C patients
- HIV-infected patients
- Pregnant women, lactating women, or patients planning to become pregnant
- If you are participating in another clinical trial administering medication
- Patients who do not agree to participate in this clinical trial
- Adults with impaired consent capacity who are unable to give consent on their own
- Those who have taken other clinical trial drugs for less than 24 weeks
- Other clinically determined by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06221657
Start Date
February 1 2024
End Date
December 31 2026
Last Update
January 24 2024
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