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

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2026-12-31

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.

Conditions

Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

TAF group

Group Type: EXPERIMENTAL

Vemlidy

Intervention Type: DRUG

1 tablet once a day, oral administration

TDF group

Group Type: ACTIVE_COMPARATOR

Virreal

Intervention Type: DRUG

1 tablet once a day, oral administration

Interventions

Vemlidy

1 tablet once a day, oral administration

Intervention Type: DRUG

Virreal

1 tablet once a day, oral administration

Intervention Type: DRUG

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Hye Won Lee

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

IIT-TAF-01

Identifier Type: -

Identifier Source: org_study_id