Acute Myeloid Leukaemia (AML)HOME-BLOODNCT07062250
Feasibility and Safety of Home Blood Count Measurement and Transfusions in Patients With Acute Myeloid Leukemia
A study testing Feasibility and safety of home-based blood count measurement and transfusions in people with Acute Myeloid Leukaemia (AML), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim is to investigate the feasibility, safety, and complication rates of patient's self-measurement of CBC and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukaemia (AML)
- What is being tested?
- Feasibility and safety of home-based blood count measurement and transfusions
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2024to 15 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- newly diagnosed with AML within four weeks
- scheduled to receive home-based chemotherapy.
Who cannot join
- Patients who do not understand or speak Danish
- Incapable of performing home-based CBC measurements and administration of transfusions.
- Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Safety of Home Blood Count Measurement and Transfusions by Systematically Educated Patients With Acute Myeloid Leukemia
The aim is to investigate the feasibility, safety, and complication rates of patient's self-measurement of CBC and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.
This study is a single-arm feasibility study with patients newly diagnosed with Acute Myeloid Leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.
Read more
Patients are included if they are ≥ 18 years old, newly diagnosed with AML within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based CBC measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
Included patients will receive comprehensive training and certification to perform CBC measurements, self-administer transfusions, and monitor selected vital parameters including blood pressure, pulse rate, oxygen saturation, and temperature.
It is hypothesized that the study can demonstrate the logistic, technical, and economic feasibility and safety of educating patients with AML undergoing intensive chemotherapy, to independently conduct self-measurement of complete blood count (CBC), self-administration of transfusions at home, and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion.
Read the detailed description
Acute Myeloid Leukemia is a serious blood cancer treated with intensive chemotherapy. Around 150 patients in Denmark receive such treatment annually. Each patient undergoes 2-4 chemotherapy cycles, each followed by a 3-4 week period of bone marrow suppression, requiring frequent blood and platelet transfusions and increasing infection risk. Patients with acute myeloid leukemia, experience prolonged chemotherapy-induced pancytopenia, lasting between 2 to 4 weeks. In our existing outpatient treatment setup, patients visit the day hospital 3 times weekly for blood measurements, clinical evaluation, and transfusions with blood and platelets.
Transfusion reactions are rare, and serious complications are even less common. While some studies have explored home transfusions administered by healthcare professionals or relatives, no studies have examined self-administered home transfusions.
Patient involvement is increasingly important in cancer care. Understanding patient experiences is key to implementing safe and successful home-based care, especially in long-term, intensive treatments. Maintaining daily life and being with loved ones during treatment are highly valued by patients and families.
In this study, we aim to instruct patients to perform complete blood count measurements and self-administration of transfusions at home, thereby reducing the need for weekly visits to the hospital. However, patients will still be required to come into the hospital for blood measurements, clinical control with their responsible physician, and transfusions once weekly.
Objective To investigate the feasibility, safety, and complication rates of patients self-measurement of complete blood count and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.
Design and methods This study is a single-arm feasibility study with patients newly diagnosed with acute myeloid leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.
Participants Patients are included if they are ≥ 18 years old, newly diagnosed with acute myeloid leukemia within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based complete blood count measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
Recruitment and Procedure Patients, n= 15 will be recruited at the outpatient clinic at the Department of Hematology, Rigshospitalet.
We will develop an educational program to facilitate certification of the patients for complete blood count self-measurements and transfusion administration. The development of the educational program will adhere to the framework outlined by the Medical Research Council for the development and evaluation of complex interventions. This education will be performed shortly after obtaining informed consent at the day hospital clinic.
The patients will receive training in drawing blood from their central venous catheter into an EDTA anticoagulated tube and in how to use HemoscreenTM. Hemoglobin and platelet values will be used to determine the need for blood and platelet transfusions. The patients will then be responsible for self-administering the blood products at the hospital under supervision by health care professionals. Patients will also learn how to administer antihistamines, acetaminophen, corticosteroids, and epinephrine either orally, subcutaneously, or intravenously following guidance from healthcare professionals at the department.
Before and after the transfusions, patients will measure their own blood pressure, pulse rate, temperature, and saturation, which is the same procedure nurses perform in relation to transfusion of blood products.
At home, patients will be responsible for independently conducting complete blood count measurements, administering transfusions, and monitoring selected vital parameters before and after transfusions, fostering their active involvement and empowerment in their treatment trajectory. Nurses at the department can always be contacted for questions and guidance. Patients will be instructed to contact the nurses in the day hospital clinic in the daytime, and the hematological ward in the evening and at night. Complete blood counts will be measured on the Hemoscreen instrument, which will feature a digital interface that allows the transfer of test results to the patient's electronic medical record at the hospital.
- Conditions
- Acute Myeloid Leukaemia (AML)
- Being tested
- Feasibility and safety of home-based blood count measurement and transfusions
- Keywords
- Home transfusion, Hematology, Blood transfusion, Home based treatment, Acute leukemia, Patient empowerment
- Medical subject headings
- Leukemia, Myeloid, Acute, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feasibility and safety of home-based blood count measurement and transfusionsDevice
Feasibility and safety of home-based blood count measurement and transfusions in patients with acute myeloid leukemia
| Study group | Role | What they receive |
|---|---|---|
| Feasibility | Experimental | Feasibility and safety of home-based blood count measurement and transfusions Receives: Device: Feasibility and safety of home-based blood count measurement and transfusions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Performance of the Hemoscreen Instrument
Number and classification of technical issues encountered by patients using the Hemoscreen instrument, including device malfunctions, failures, and errors in transmission of complete blood count (CBC) measurements. Recorded per transfusion event through hospital records and patient reports; categorized by issue type (e.g., hardware failure, data transmission error).
Measured: Assessed throughout each participant's enrollment period, up to 12 weeks.
Self-Administered Blood Measurements at Home
Number of CBC measurements performed by patients at home using the Hemoscreen instrument. Extracted from hospital records and participants' self-reporting.
Measured: Recorded continuously during each participant's enrollment, up to 12 weeks.
Self-Administered Blood and Platelet Transfusions at Home
Number of blood and platelet transfusions self-administered at home without direct hospital supervision. Extracted from hospital records and participants' self-reporting.
Measured: Recorded continuously during each participant's enrollment, up to 12 weeks.
Replacement of Scheduled Day Hospital Visits by Home Care and Self-Testing
Number of scheduled day hospital visits replaced by successful self-testing and home transfusions. Determined by comparing hospital visit records with home care study documentation.
Measured: Recorded continuously during each participant's enrollment, up to 12 weeks.
Vital Signs Before and After Home Transfusions
Vital parameters including temperature (°C), pulse rate (beats per minute), and blood pressure (mmHg) measured immediately before and after each home transfusion.
Measurement: Collected by participants using standardized home monitoring devices and confirmed during nursing visits.
Measured: Recorded at each home transfusion event during the participant's 12-week enrollment.
Extra Healthcare Visits and Hospital Admissions
Number, cause, and duration (days) of unplanned extra visits to the day hospital or inpatient ward related to transfusion or device complications. Data collected from hospital records.
Measured: Recorded continuously during each participant's enrollment, up to 12 weeks.
Transfusion Reactions and Adverse Events
Number and severity of transfusion reactions, including serious infusion reactions necessitating hospital admission.
Documented by clinicians and participant self-reporting; hospital admissions verified through records.
Measured: Assessed continuously during and for 24 hours post-transfusion within each participant's study period, up to 12 weeks.
Types of Transfusion Reactions
Frequency and types of transfusion reactions, categorized as fever, shivering, hypotension, hypertension, hives, nausea, pain, malaise, allergic reactions, or others.
Recorded using a standardized transfusion reaction form during clinical assessments and participant self-reports.
Measured: Recorded at each transfusion event during each participant's enrollment up to 12-week study period.
Secondary outcomes (2)
Change in Quality of Life scores from EORTC QLQ-C30 at baseline and post-second chemotherapy
Quality of Life assessed using the validated EORTC QLQ-C30 questionnaire, which evaluates multiple dimensions of QoL in cancer patients.Patients will complete the QLQ-C30 questionnaire at two time points: at study entry (baseline) and after second chemotherapy course to monitor for any QoL deterioration during participation.
Quality of life is measured by the validated QOL-EORTC30 questionnaire at inclusion and end of study. Data will be collected via patient self-report during scheduled visits or remotely as appropriate.
Measured: Assessed over the course of each participant's study period, approximately 12 weeks.
Empowerment
Level of patient empowerment and satisfaction as measured by the Patient Empowerment Scale (cancer), a validated questionnaire assessing patients' sense of empowerment related to their care. Patients will complete the Patient Empowerment Scale at two time points: at study entry (baseline) and after the second chemotherapy course. Data will be collected via patient self-report during scheduled visits or remotely as appropriate.
Measured: Assessed over the course of each participant's study period, approximately 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start1 Apr 2024
- Primary completion15 Aug 2026
- Study completion15 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukaemia (AML)Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Iben Husted Nielsen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Lars Kjeldsen, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062250
- Sponsor's protocol ID
- p-2023-14481
- Acronym
- HOME-BLOOD
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Home Blood Count Measurement and Transfusions by Systematically Educated Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07062250
- Acronym / sponsor ID
- HOME-BLOOD / p-2023-14481
- Conditions
- Acute Myeloid Leukaemia (AML)
- Keywords
- Home transfusion, Hematology, Blood transfusion, Home based treatment, Acute leukemia, Patient empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 15 Aug 2026 (actual)
- Study completion
- 15 Aug 2026 (actual)
- First posted
- 14 Jul 2025 (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.
The aim is to investigate the feasibility, safety, and complication rates of patient's self-measurement of CBC and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.
This study is a single-arm feasibility study with patients newly diagnosed with Acute Myeloid Leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.
Patients are included if they are ≥ 18 years old, newly diagnosed with AML within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based CBC measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
Included patients will receive comprehensive training and certification to perform CBC measurements, self-administer transfusions, and monitor selected vital parameters including blood pressure, pulse rate, oxygen saturation, and temperature.
It is hypothesized that the study can demonstrate the logistic, technical, and economic feasibility and safety of educating patients with AML undergoing intensive chemotherapy, to independently conduct self-measurement of complete blood count (CBC), self-administration of transfusions at home, and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion.
Detailed description
Acute Myeloid Leukemia is a serious blood cancer treated with intensive chemotherapy. Around 150 patients in Denmark receive such treatment annually. Each patient undergoes 2-4 chemotherapy cycles, each followed by a 3-4 week period of bone marrow suppression, requiring frequent blood and platelet transfusions and increasing infection risk. Patients with acute myeloid leukemia, experience prolonged chemotherapy-induced pancytopenia, lasting between 2 to 4 weeks. In our existing outpatient treatment setup, patients visit the day hospital 3 times weekly for blood measurements, clinical evaluation, and transfusions with blood and platelets.
Transfusion reactions are rare, and serious complications are even less common. While some studies have explored home transfusions administered by healthcare professionals or relatives, no studies have examined self-administered home transfusions.
Patient involvement is increasingly important in cancer care. Understanding patient experiences is key to implementing safe and successful home-based care, especially in long-term, intensive treatments. Maintaining daily life and being with loved ones during treatment are highly valued by patients and families.
In this study, we aim to instruct patients to perform complete blood count measurements and self-administration of transfusions at home, thereby reducing the need for weekly visits to the hospital. However, patients will still be required to come into the hospital for blood measurements, clinical control with their responsible physician, and transfusions once weekly.
Objective To investigate the feasibility, safety, and complication rates of patients self-measurement of complete blood count and self-administration of blood and platelet transfusions at home and examine the performance of patients conducting at-home monitoring of their blood pressure, pulse rate, saturation, and temperature before and after transfusion. Furthermore, to evaluate the health economic consequences of our innovative approach, specifically, the anticipated reduction in reliance on nurse-driven services.
Design and methods This study is a single-arm feasibility study with patients newly diagnosed with acute myeloid leukemia. The study will be conducted at the Department of Hematology, Rigshospitalet.
Participants Patients are included if they are ≥ 18 years old, newly diagnosed with acute myeloid leukemia within four weeks, and scheduled to receive home-based chemotherapy. Patients are excluded if they do not speak Danish or are not assessed to be capable of performing home-based complete blood count measurements and administration of transfusions. Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
Recruitment and Procedure Patients, n= 15 will be recruited at the outpatient clinic at the Department of Hematology, Rigshospitalet.
We will develop an educational program to facilitate certification of the patients for complete blood count self-measurements and transfusion administration. The development of the educational program will adhere to the framework outlined by the Medical Research Council for the development and evaluation of complex interventions. This education will be performed shortly after obtaining informed consent at the day hospital clinic.
The patients will receive training in drawing blood from their central venous catheter into an EDTA anticoagulated tube and in how to use HemoscreenTM. Hemoglobin and platelet values will be used to determine the need for blood and platelet transfusions. The patients will then be responsible for self-administering the blood products at the hospital under supervision by health care professionals. Patients will also learn how to administer antihistamines, acetaminophen, corticosteroids, and epinephrine either orally, subcutaneously, or intravenously following guidance from healthcare professionals at the department.
Before and after the transfusions, patients will measure their own blood pressure, pulse rate, temperature, and saturation, which is the same procedure nurses perform in relation to transfusion of blood products.
At home, patients will be responsible for independently conducting complete blood count measurements, administering transfusions, and monitoring selected vital parameters before and after transfusions, fostering their active involvement and empowerment in their treatment trajectory. Nurses at the department can always be contacted for questions and guidance. Patients will be instructed to contact the nurses in the day hospital clinic in the daytime, and the hematological ward in the evening and at night. Complete blood counts will be measured on the Hemoscreen instrument, which will feature a digital interface that allows the transfer of test results to the patient's electronic medical record at the hospital.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Feasibility | Experimental | Device: Feasibility and safety of home-based blood count measurement and transfusionsFeasibility and safety of home-based blood count measurement and transfusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old
- newly diagnosed with AML within four weeks
- scheduled to receive home-based chemotherapy.
Key exclusion criteria (3 listed)
- Patients who do not understand or speak Danish
- Incapable of performing home-based CBC measurements and administration of transfusions.
- Patients will be discontinued if they do not achieve remission after the second chemotherapy cycle.
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 |
|---|---|---|
| Feasibility and safety of home-based blood count measurement and transfusionsFeasibility and safety of home-based blood count measurement and transfusions in patients with acute myeloid leukemia | Device | Feasibility |
Primary outcome
Technical Performance of the Hemoscreen Instrument
Time frame: Assessed throughout each participant's enrollment period, up to 12 weeks.
Number and classification of technical issues encountered by patients using the Hemoscreen instrument, including device malfunctions, failures, and errors in transmission of complete blood count (CBC) measurements. Recorded per transfusion event through hospital records and patient reports; categorized by issue type (e.g., hardware failure, data transmission error).
Self-Administered Blood Measurements at Home
Time frame: Recorded continuously during each participant's enrollment, up to 12 weeks.
Number of CBC measurements performed by patients at home using the Hemoscreen instrument. Extracted from hospital records and participants' self-reporting.
Self-Administered Blood and Platelet Transfusions at Home
Time frame: Recorded continuously during each participant's enrollment, up to 12 weeks.
Number of blood and platelet transfusions self-administered at home without direct hospital supervision. Extracted from hospital records and participants' self-reporting.
Replacement of Scheduled Day Hospital Visits by Home Care and Self-Testing
Time frame: Recorded continuously during each participant's enrollment, up to 12 weeks.
Number of scheduled day hospital visits replaced by successful self-testing and home transfusions. Determined by comparing hospital visit records with home care study documentation.
Vital Signs Before and After Home Transfusions
Time frame: Recorded at each home transfusion event during the participant's 12-week enrollment.
Vital parameters including temperature (°C), pulse rate (beats per minute), and blood pressure (mmHg) measured immediately before and after each home transfusion. Measurement: Collected by participants using standardized home monitoring devices and confirmed during nursing visits.
Extra Healthcare Visits and Hospital Admissions
Time frame: Recorded continuously during each participant's enrollment, up to 12 weeks.
Number, cause, and duration (days) of unplanned extra visits to the day hospital or inpatient ward related to transfusion or device complications. Data collected from hospital records.
Transfusion Reactions and Adverse Events
Time frame: Assessed continuously during and for 24 hours post-transfusion within each participant's study period, up to 12 weeks.
Number and severity of transfusion reactions, including serious infusion reactions necessitating hospital admission. Documented by clinicians and participant self-reporting; hospital admissions verified through records.
Types of Transfusion Reactions
Time frame: Recorded at each transfusion event during each participant's enrollment up to 12-week study period.
Frequency and types of transfusion reactions, categorized as fever, shivering, hypotension, hypertension, hives, nausea, pain, malaise, allergic reactions, or others. Recorded using a standardized transfusion reaction form during clinical assessments and participant self-reports.
2 secondary outcomes
Change in Quality of Life scores from EORTC QLQ-C30 at baseline and post-second chemotherapy
Time frame: Assessed over the course of each participant's study period, approximately 12 weeks.
Empowerment
Time frame: Assessed over the course of each participant's study period, approximately 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Lars Kjeldsen, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feasibility and safety of home-based blood count measurement and transfusions in people with Acute Myeloid Leukaemia (AML), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Technical Performance of the Hemoscreen Instrument (time frame: Assessed throughout each participant's enrollment period, up to 12 weeks.). The study lists 8 primary outcomes in all. 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 9 Sep 2026.