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

NCT06221657 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IIT-TAF-01
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects maintained at HBV DNA <29 IU/mL

  48 weeks

Secondary Outcomes (9)

• 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

Study Arms (2)

TAF group

EXPERIMENTAL

Drug: Vemlidy

TDF group

ACTIVE COMPARATOR

Drug: Virreal

Interventions

Vemlidy DRUG

1 tablet once a day, oral administration

TAF group

Virreal DRUG

1 tablet once a day, oral administration

TDF group

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yonsei University: lead

MeSH Terms

Interventions

tenofovir alafenamide

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 24, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 24, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share