Sickle Cell DiseaseDREPNANONCT05530239
Nano-rheological Biomarkers for Patients With Sickle Cell Disease (SCD) Versus Control Subjects (Other Constitutional Red Blood Cell Diseases and Healthy Subjects)
An observational study of Sickle Cell Disease, run by University Hospital, Grenoble.
Trial summary
Numerous pathologies (sickle cell disease, thalassemia, spherocytosis, etc.) lead to changes in the rheological properties of the blood, in particular via alterations in the deformability of red blood cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Blood sample collection
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Oct 2022to Nov 2025
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population will be patient with sickle cell disease (SCD) in comparaison of two populations : healthy volunteers (living donor of kidney) and patient with a constitutional non-sickle cell disease of the red blood cell, or an acquired red blood cell disease
Who may be able to join
- Patient age ≥ 18 years
- With social care protection
- Living donor recruited for kidney donation with normal blood count
- Patient age ≥ 18 years
- With social care protection
- SCD patient with documented phenotype: SS, S°, S+, SC, SLepore, SOrab, SDPundjab, ASantilles... with or without specific treatment
Show all 17Show fewer
- Inclusion Criteria for patient with a constitutional non-sickle cell disease of the red blood cell, or an acquired red blood cell disease :
- Patient age ≥ 18 years
- With social care protection
- With any of the following conditions :
- Patient being managed for anemia due to martial deficiency, and prior to oral or intravenous replacement therapy
- Patient being followed for myeloproliferative syndrome at diagnosis, and prior to any specific treatment (hemodilution or hydroxycarbamide or other specific treatment)
- A patient with a MCGRE other than a major sickle cell syndrome, whether or not under specific treatment
- Hemoglobinopathy: transfusion-dependent or independent thalassemias (major or intermediate), thalassemias minor, heterozygous sickle cell trait A/S, other heterozygous hemoglobin variants (C, E, Lepore...), hyperaffine hemoglobin
- Membrane disorders (hereditary spherocytosis)
- Canalopathies (stomatocytosis with dehydrated or hyperhydrated erythrocytes, melanesian ovalocytosis...)
- Enzyme deficiencies (G6PD, PK, GPI...)
Who cannot join
- Patient age < 18 years
- Subject under guardianship, or subject deprived of freedom
- Linguistic or literacy status not allowing for informed consent despite patient information in "Easy to Read and Understand" format
- Known history of HIV, HTLV, syphilis, or positive serology and active viral hepatitis B or C.
- Additional Exclusion Criteria for healthy volunteers :
- Abnormal blood count, or possible martial deficiency with ferritin levels below 50µg/l, or current treatment with hydroxycarbamide, or transfusion within 4 months prior to inclusion.
Show all 11Show fewer
- Additional Exclusion Criteria for SCD patient :
- 5) Treatment with hydroxycarbamide started less than 6 months ago 6) Anemia with hemoglobin level <60g/l in the absence of cardiorespiratory pathology, <70g/l in pregnancy, or in the presence of cardiorespiratory pathology that may alter the tolerance of anemia.
- Additional Exclusion Criteria for patient with a constitutional non-sickle cell disease of the red blood cell, or an acquired red blood cell disease :
- 5) Anemia with hemoglobin level <60g/l, <70g/l in pregnancy, or in the presence of cardio-respiratory pathology that may alter the tolerance of anemia.
- 6) Diagnosis not finalized (in progress), or uncertain nosological framework, or diagnostic wandering.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Single-center Pilot Study: Nano-rheological Biomarkers for Patients With Sickle Cell Disease (SCD) Versus Control Subjects (Other Constitutional Red Blood Cell Diseases and Healthy Subjects)
Numerous pathologies (sickle cell disease, thalassemia, spherocytosis, etc.) lead to changes in the rheological properties of the blood, in particular via alterations in the deformability of red blood cells. These alterations lead to circulatory complications of which an emblematic example is the sickle cell crisis which manifests itself by microcirculatory occlusions. Several authors suggest that the deformability of erythrocytes is a key parameter for the diagnosis and monitoring of patients. Numerous studies, especially in vitro, show that the mechanical properties of the red blood cell significantly influence its dynamics in flow (blood viscosity, distribution in capillary networks). Moreover, concerning the specific problem of vaso-occlusion, the proportion of the most rigid red blood cells is a determining factor of the probability of occlusion more than the average value of this rigidity which can hide great disparities.
There is no clinically usable test to assess the alteration of the fine rheology of the red blood cell in a patient. Functional tests such as ektacytometry require heavy equipment and teams of specialized biologists; this technique is therefore only available in 3 biological reference centers in France. "Mechanical phenotyping" seems to be a potentially simpler and more accessible technique, and has already shown promising prospects in other nosological settings than red blood cell pathologies.
Today, there is no specific marker of sickle cell vaso-occlusive crisis, nor marker of severity, that would be useful for pathophysiological understanding but also for clinical management.
Read the detailed description
This study aims to characterize the microfluidic flow and intra-erythrocyte viscosity of sickle cell red blood cells, and to identify specific biological phenotype or clinical severity profiles. The techniques used are microfluidic circuits for the study of flow and molecular rotors for the measurement of intra-erythrocyte viscosity, using deoxygenation cycles in order to model physio-pathological situations.
The first part will allow the calibration of the microfluidic techniques used (microfluidic circuit and molecular rotors), testing blood from healthy subjects (without constitutional or acquired red blood cell pathology) and blood from SCD patients. The aim is to define the reproducibility and sensitivity of the techniques.
A second part is aimed at establishing a rheological profile of the blood of patients with SCD in comparison with blood from control subjects, i.e. with other constitutional or acquired red blood cell pathology.
- Conditions
- Sickle Cell Disease
- Being tested
- Blood sample collection
- Keywords
- Hemorheology, Microfluidics, Blood viscosity, Red blood cell, Sickle cell disease
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionOther
Blood sample collection
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Subjects with no documented hematological pathology (neither constitutional nor acquired). From the recruitment of living kidney donors, transplantation unit of Grenoble Alpes University Hospital Receives: Other: Blood sample collection | |
| SCD patients | Patients with SCD Receives: Other: Blood sample collection | |
| Control patients | With a constitutional non-sickle cell disease of the red blood cell, or an acquired red blood cell disease. Receives: Other: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of the intra-erythrocyte viscosity dispersion and rheological profile of red blood cells
Measure of the intra-erythrocyte viscosity dispersion using molecular rotors technique, study of rheological profile of red blood cells in microfluidic circuit : measure of the speed of flowing, and DI deformability Index [DI = (L-W)/(L+W)] of each red blood cell, DI dispersion in each sample, in basal state and after exposure to deoxygenation cycles of blood SCD patients versus control subjects.
Measured: 30 months
Secondary outcomes (1)
Study of the intra-erythrocyte viscosity dispersion and rheological profile of red blood cells
Measure of the intra-erythrocyte viscosity dispersion using molecular rotors technique, study of rheological profile of red blood cells in microfluidic circuit : measure of the speed of flowing, and DI deformability Index [DI = (L-W)/(L+W)] of each red blood cell, DI dispersion in each sample, in basal state and after exposure to deoxygenation cycles in different conditions : congenital red blood cell disorders, acquired red blood cell disorders and clinical events (vasoocclusive crisis, pregnancy, infection).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study startOct 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (30)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caroline MAKOWSKI, mD, Principal investigator, CHU Grenoble Alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530239
- Sponsor's protocol ID
- 38RC22.0135
- Acronym
- DREPNANO
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 22 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arlet JB. [A new therapeutic era in sickle cell disease]. Rev Med Interne. 2017 Sep;38(9):569-571. doi: 10.1016/j.revmed.2017.05.006. Epub 2017 Jun 16. No abstract available. French.
PubMed 28624233Ataga KI, Kutlar A, Kanter J. Crizanlizumab in Sickle Cell Disease. N Engl J Med. 2017 May 4;376(18):1796. doi: 10.1056/NEJMc1703162. No abstract available.
PubMed 28467874Ballas SK, Barton FB, Waclawiw MA, Swerdlow P, Eckman JR, Pegelow CH, Koshy M, Barton BA, Bonds DR. Hydroxyurea and sickle cell anemia: effect on quality of life. Health Qual Life Outcomes. 2006 Aug 31;4:59. doi: 10.1186/1477-7525-4-59.
PubMed 16942629Ballas SK. The Evolving Pharmacotherapeutic Landscape for the Treatment of Sickle Cell Disease. Mediterr J Hematol Infect Dis. 2020 Jan 1;12(1):e2020010. doi: 10.4084/MJHID.2020.010. eCollection 2020.
PubMed 31934320Baez S, Kaul DK, Nagel RL. Microvascular determinants of blood flow behavior and HbSS erythrocyte plugging in microcirculation. Blood Cells. 1982;8(1):127-37. No abstract available.
PubMed 7115970Banerjee R, Nageshwari K, Puniyani RR. The diagnostic relevance of red cell rigidity. Clin Hemorheol Microcirc. 1998 Sep;19(1):21-4.
PubMed 9806729Bartolucci P, Brugnara C, Teixeira-Pinto A, Pissard S, Moradkhani K, Jouault H, Galacteros F. Erythrocyte density in sickle cell syndromes is associated with specific clinical manifestations and hemolysis. Blood. 2012 Oct 11;120(15):3136-41. doi: 10.1182/blood-2012-04-424184. Epub 2012 Aug 23.
PubMed 22919030Briole A, Podgorski T, Abou B. Molecular rotors as intracellular probes of red blood cell stiffness. Soft Matter. 2021 May 5;17(17):4525-4537. doi: 10.1039/d1sm00321f.
PubMed 33949619Connes P, Alexy T, Detterich J, Romana M, Hardy-Dessources MD, Ballas SK. The role of blood rheology in sickle cell disease. Blood Rev. 2016 Mar;30(2):111-8. doi: 10.1016/j.blre.2015.08.005. Epub 2015 Aug 28.
PubMed 26341565Du E, Diez-Silva M, Kato GJ, Dao M, Suresh S. Kinetics of sickle cell biorheology and implications for painful vasoocclusive crisis. Proc Natl Acad Sci U S A. 2015 Feb 3;112(5):1422-7. doi: 10.1073/pnas.1424111112. Epub 2015 Jan 20.
PubMed 25605910Faivre M, Renoux C, Bessaa A, Da Costa L, Joly P, Gauthier A, Connes P. Mechanical Signature of Red Blood Cells Flowing Out of a Microfluidic Constriction Is Impacted by Membrane Elasticity, Cell Surface-to-Volume Ratio and Diseases. Front Physiol. 2020 Jun 12;11:576. doi: 10.3389/fphys.2020.00576. eCollection 2020.
PubMed 32595519Gladwin MT, Vichinsky E. Pulmonary complications of sickle cell disease. N Engl J Med. 2008 Nov 20;359(21):2254-65. doi: 10.1056/NEJMra0804411. No abstract available.
PubMed 19020327Guo Q, Duffy SP, Matthews K, Santoso AT, Scott MD, Ma H. Microfluidic analysis of red blood cell deformability. J Biomech. 2014 Jun 3;47(8):1767-76. doi: 10.1016/j.jbiomech.2014.03.038. Epub 2014 Apr 5.
PubMed 24767871Gossett DR, Tse HT, Lee SA, Ying Y, Lindgren AG, Yang OO, Rao J, Clark AT, Di Carlo D. Hydrodynamic stretching of single cells for large population mechanical phenotyping. Proc Natl Acad Sci U S A. 2012 May 15;109(20):7630-5. doi: 10.1073/pnas.1200107109. Epub 2012 Apr 30.
PubMed 22547795Hamideh D, Alvarez O. Sickle cell disease related mortality in the United States (1999-2009). Pediatr Blood Cancer. 2013 Sep;60(9):1482-6. doi: 10.1002/pbc.24557. Epub 2013 Apr 23.
PubMed 23637037
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center Pilot Study: Nano-rheological Biomarkers for Patients With Sickle Cell Disease (SCD) Versus Control Subjects (Other Constitutional Red Blood Cell Diseases and Healthy Subjects)
- ClinicalTrials.gov ID
- NCT05530239
- Acronym / sponsor ID
- DREPNANO / 38RC22.0135
- Conditions
- Sickle Cell Disease
- Keywords
- Hemorheology, Microfluidics, Blood viscosity, Red blood cell, Sickle cell disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 7 Sep 2022 (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.
Numerous pathologies (sickle cell disease, thalassemia, spherocytosis, etc.) lead to changes in the rheological properties of the blood, in particular via alterations in the deformability of red blood cells. These alterations lead to circulatory complications of which an emblematic example is the sickle cell crisis which manifests itself by microcirculatory occlusions. Several authors suggest that the deformability of erythrocytes is a key parameter for the diagnosis and monitoring of patients. Numerous studies, especially in vitro, show that the mechanical properties of the red blood cell significantly influence its dynamics in flow (blood viscosity, distribution in capillary networks). Moreover, concerning the specific problem of vaso-occlusion, the proportion of the most rigid red blood cells is a determining factor of the probability of occlusion more than the average value of this rigidity which can hide great disparities.
There is no clinically usable test to assess the alteration of the fine rheology of the red blood cell in a patient. Functional tests such as ektacytometry require heavy equipment and teams of specialized biologists; this technique is therefore only available in 3 biological reference centers in France. "Mechanical phenotyping" seems to be a potentially simpler and more accessible technique, and has already shown promising prospects in other nosological settings than red blood cell pathologies.
Today, there is no specific marker of sickle cell vaso-occlusive crisis, nor marker of severity, that would be useful for pathophysiological understanding but also for clinical management.
Detailed description
This study aims to characterize the microfluidic flow and intra-erythrocyte viscosity of sickle cell red blood cells, and to identify specific biological phenotype or clinical severity profiles. The techniques used are microfluidic circuits for the study of flow and molecular rotors for the measurement of intra-erythrocyte viscosity, using deoxygenation cycles in order to model physio-pathological situations.
The first part will allow the calibration of the microfluidic techniques used (microfluidic circuit and molecular rotors), testing blood from healthy subjects (without constitutional or acquired red blood cell pathology) and blood from SCD patients. The aim is to define the reproducibility and sensitivity of the techniques.
A second part is aimed at establishing a rheological profile of the blood of patients with SCD in comparison with blood from control subjects, i.e. with other constitutional or acquired red blood cell pathology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Blood sample collectionSubjects with no documented hematological pathology (neither constitutional nor acquired). From the recruitment of living kidney donors, transplantation unit of Grenoble Alpes University Hospital |
| SCD patients | – | Other: Blood sample collectionPatients with SCD |
| Control patients | – | Other: Blood sample collectionWith a constitutional non-sickle cell disease of the red blood cell, or an acquired red blood cell disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be patient with sickle cell disease (SCD) in comparaison of two populations : healthy volunteers (living donor of kidney) and patient with a constitutional non-sickle cell disease of the red blood cell, or an acquired red blood cell disease
Key inclusion criteria (17 listed)
- Patient age ≥ 18 years
- With social care protection
- Living donor recruited for kidney donation with normal blood count
- Patient age ≥ 18 years
- With social care protection
Key exclusion criteria (11 listed)
- Patient age < 18 years
- Subject under guardianship, or subject deprived of freedom
- Linguistic or literacy status not allowing for informed consent despite patient information in "Easy to Read and Understand" format
- Known history of HIV, HTLV, syphilis, or positive serology and active viral hepatitis B or C.
- Abnormal blood count, or possible martial deficiency with ferritin levels below 50µg/l, or current treatment with hydroxycarbamide, or transfusion within 4 months prior to inclusion.
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 |
|---|---|---|
| Blood sample collectionBlood sample collection | Other | Control patients, Healthy subjects, SCD patients |
Primary outcome
Study of the intra-erythrocyte viscosity dispersion and rheological profile of red blood cells
Time frame: 30 months
Measure of the intra-erythrocyte viscosity dispersion using molecular rotors technique, study of rheological profile of red blood cells in microfluidic circuit : measure of the speed of flowing, and DI deformability Index [DI = (L-W)/(L+W)] of each red blood cell, DI dispersion in each sample, in basal state and after exposure to deoxygenation cycles of blood SCD patients versus control subjects.
1 secondary outcome
Study of the intra-erythrocyte viscosity dispersion and rheological profile of red blood cells
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2022.
- Background: PubMed 28624233Arlet JB. [A new therapeutic era in sickle cell disease]. Rev Med Interne. 2017 Sep;38(9):569-571. doi: 10.1016/j.revmed.2017.05.006. Epub 2017 Jun 16. No abstract available. French.
- Background: PubMed 28467874Ataga KI, Kutlar A, Kanter J. Crizanlizumab in Sickle Cell Disease. N Engl J Med. 2017 May 4;376(18):1796. doi: 10.1056/NEJMc1703162. No abstract available.
- Background: PubMed 16942629Ballas SK, Barton FB, Waclawiw MA, Swerdlow P, Eckman JR, Pegelow CH, Koshy M, Barton BA, Bonds DR. Hydroxyurea and sickle cell anemia: effect on quality of life. Health Qual Life Outcomes. 2006 Aug 31;4:59. doi: 10.1186/1477-7525-4-59.
- Background: PubMed 31934320Ballas SK. The Evolving Pharmacotherapeutic Landscape for the Treatment of Sickle Cell Disease. Mediterr J Hematol Infect Dis. 2020 Jan 1;12(1):e2020010. doi: 10.4084/MJHID.2020.010. eCollection 2020.
- Background: PubMed 7115970Baez S, Kaul DK, Nagel RL. Microvascular determinants of blood flow behavior and HbSS erythrocyte plugging in microcirculation. Blood Cells. 1982;8(1):127-37. No abstract available.
- Background: PubMed 9806729Banerjee R, Nageshwari K, Puniyani RR. The diagnostic relevance of red cell rigidity. Clin Hemorheol Microcirc. 1998 Sep;19(1):21-4.
- Background: PubMed 22919030Bartolucci P, Brugnara C, Teixeira-Pinto A, Pissard S, Moradkhani K, Jouault H, Galacteros F. Erythrocyte density in sickle cell syndromes is associated with specific clinical manifestations and hemolysis. Blood. 2012 Oct 11;120(15):3136-41. doi: 10.1182/blood-2012-04-424184. Epub 2012 Aug 23.
- Background: PubMed 33949619Briole A, Podgorski T, Abou B. Molecular rotors as intracellular probes of red blood cell stiffness. Soft Matter. 2021 May 5;17(17):4525-4537. doi: 10.1039/d1sm00321f.
- Background: PubMed 26341565Connes P, Alexy T, Detterich J, Romana M, Hardy-Dessources MD, Ballas SK. The role of blood rheology in sickle cell disease. Blood Rev. 2016 Mar;30(2):111-8. doi: 10.1016/j.blre.2015.08.005. Epub 2015 Aug 28.
- Background: PubMed 25605910Du E, Diez-Silva M, Kato GJ, Dao M, Suresh S. Kinetics of sickle cell biorheology and implications for painful vasoocclusive crisis. Proc Natl Acad Sci U S A. 2015 Feb 3;112(5):1422-7. doi: 10.1073/pnas.1424111112. Epub 2015 Jan 20.
- Background: PubMed 32595519Faivre M, Renoux C, Bessaa A, Da Costa L, Joly P, Gauthier A, Connes P. Mechanical Signature of Red Blood Cells Flowing Out of a Microfluidic Constriction Is Impacted by Membrane Elasticity, Cell Surface-to-Volume Ratio and Diseases. Front Physiol. 2020 Jun 12;11:576. doi: 10.3389/fphys.2020.00576. eCollection 2020.
- Background: PubMed 19020327Gladwin MT, Vichinsky E. Pulmonary complications of sickle cell disease. N Engl J Med. 2008 Nov 20;359(21):2254-65. doi: 10.1056/NEJMra0804411. No abstract available.
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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.
Caroline MAKOWSKI, mD principal investigator
CHU Grenoble Alpes
Questions about this trial
What is this clinical trial studying?
An observational study of Sickle Cell Disease, run by University Hospital, Grenoble.
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 17 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Sep 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caroline MAKOWSKI, Md (+33476767640, cmakowski@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study of the intra-erythrocyte viscosity dispersion and rheological profile of red blood cells (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05530239, which also lists 30 linked publications.
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 22 Sep 2022.