Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral MedicationPhase 4NCT06221657
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 Phase 4 study testing Vemlidy and Virreal in people with Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication
- What is being tested?
- Vemlidy and Virreal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
About this study
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
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.
- Being tested
- Vemlidy, Virreal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VemlidyDrug
1 tablet once a day, oral administration
VirrealDrug
1 tablet once a day, oral administration
| Study group | Role | What they receive |
|---|---|---|
| TAF group | Experimental | Not described Receives: Drug: Vemlidy |
| TDF group | Active comparator | Not described Receives: Drug: Virreal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects maintained at HBV DNA <29 IU/mL
Measured: 48 weeks
Secondary outcomes (9)
Proportion of subjects maintaining HBV DNA <29 IU/mL
Measured: 72 weeks
Proportion of subjects with serum HBV DNA <60 IU/mL
Measured: 12, 24, 48, 72 weeks
Proportion of subjects maintaining HBV DNA <10 IU/mL
Measured: 12, 24, 48, 72 weeks
Level of AST, ALT, r-GTP
Measured: 12, 24, 48, 72 weeks
total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride
Measured: 12, 24, 48, 72 weeks
level of e-GFR
Measured: 12, 24, 48, 72 weeks
creatinine clearance rate
Measured: 12, 24, 48, 72 weeks
BMD T Score
Measured: 24, 48, 72 weeks
blood Phosphorus levels
Measured: 12, 24, 48, 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral MedicationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hye Won Lee, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221657
- Sponsor's protocol ID
- IIT-TAF-01
- Status last verified
- Jan 2024
- First submitted
- 15 Jan 2024
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06221657
- Acronym / sponsor ID
- IIT-TAF-01
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAF group | Experimental | Drug: Vemlidy |
| TDF group | Active comparator | Drug: Virreal |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- HBcAb positive patient
- Patients who voluntarily agreed to participate in this clinical trial and signed a written consent form
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vemlidy1 tablet once a day, oral administration | Drug | TAF group |
| Virreal1 tablet once a day, oral administration | Drug | TDF group |
Primary outcome
Proportion of subjects maintained at HBV DNA <29 IU/mL
Time frame: 48 weeks
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vemlidy and Virreal in people with Patients With Malignant Blood Disease Requiring Hepatitis B Antiviral Medication, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects maintained at HBV DNA <29 IU/mL (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.