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Not yet recruiting NCT06221657

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

Phase IV Interventional Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Vemlidy, Virreal.
Who it may be relevant to
Registry conditions: Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication. Basic parameters: 19 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Vemlidy
    1 tablet once a day, oral administration
  • Drug Virreal
    1 tablet once a day, oral administration

Primary outcome measures

  • Proportion of subjects maintained at HBV DNA <29 IU/mL [Time frame: 48 weeks]
Secondary outcome measures (9)
  • Proportion of subjects maintaining HBV DNA <29 IU/mL [Time frame: 72 weeks]
  • Proportion of subjects with serum HBV DNA <60 IU/mL [Time frame: 12, 24, 48, 72 weeks]
  • Proportion of subjects maintaining HBV DNA <10 IU/mL [Time frame: 12, 24, 48, 72 weeks]
  • Level of AST, ALT, r-GTP [Time frame: 12, 24, 48, 72 weeks]
  • total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride [Time frame: 12, 24, 48, 72 weeks]
  • level of e-GFR [Time frame: 12, 24, 48, 72 weeks]
  • creatinine clearance rate [Time frame: 12, 24, 48, 72 weeks]
  • BMD T Score [Time frame: 24, 48, 72 weeks]
  • blood Phosphorus levels [Time frame: 12, 24, 48, 72 weeks]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06221657 · IIT-TAF-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗