NCT06221657Not yet recruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 24 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 15 Jan 2024
- Start date
- 1 Feb 2024
- Primary completion date
- 1 Dec 2026
- Lead sponsor
- Yonsei University
- Diseases
- Hepatitis B
- NCT number
- NCT06221657
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 1 Feb 2024 to the primary completion date, 1 Dec 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- If you are participating in another clinical trial administering medication
- Those who have taken other clinical trial drugs for less than 24 weeks
Other illness
- Patients taking oral chronic hepatitis B antiviral drugs before starting the study
- Patients with hypersensitivity to tenofovir alafenamide citrate or tenofovir disoproxil orotate
- Hepatitis C patients
- HIV-infected patients
Lab values
- Galactose intolerance. Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption
- Patients with abnormal renal function (e-GFR less than 15mL/min) or end-stage renal disease requiring dialysis
Other
- Pregnant women, lactating women, or patients planning to become pregnant
- 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
- Other clinically determined by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial.
Who the study is looking for
- 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.
- 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
Age in the registry: 19 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.