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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication
• Intervention / Treatment: Drug: Vemlidy; Drug: Virreal

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAF group	Drug: Vemlidy; 1 tablet once a day, oral administration
Active Comparator: TDF group	Drug: Virreal; 1 tablet once a day, oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects maintained at HBV DNA <29 IU/mL	48 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects maintaining HBV DNA <29 IU/mL	72 weeks
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
level of e-GFR	12, 24, 48, 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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: January 23, 2024
• First Posted (Actual): January 24, 2024

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Neoplasms; Neoplasms by Site; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hematologic Neoplasms; Hepatitis B; Hepatitis; Hepatitis A; Hematologic Diseases
• Other Study ID Numbers: IIT-TAF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No