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hCT-MSC hos børn med autismespektrumforstyrrelse (IMPACT)

28. maj 2026 opdateret af: Joanne Kurtzberg, MD

Et fase II-studie af hCT-MSC, et navlestrengs-afledt mesenkymalt stromalcelleprodukt, hos børn med autismespektrumforstyrrelse

Formålet med dette fase II-studie er at bestemme effektiviteten af ​​humane navlestrengsvæv-afledte mesenchymale stromaceller (hCT-MSC) til at forbedre sociale kommunikationsevner hos børn med autismespektrumforstyrrelse (ASD).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Formålet med dette dobbeltblindede fase II-studie er at bestemme effektiviteten af ​​humane navlestrengsvæv-afledte mesencymale stromaceller (hCT-MSC), indgivet i to forskellige doseringsstrategier, til børn med autismespektrumforstyrrelse (ASD).

Denne undersøgelse vil omfatte børn med ASD i alderen 4-11 år. Kvalificerende forsøgspersoner vil gennemgå neuropsykologisk evaluering, EEG-test, øjensporing, CVA-vurderinger og infusion af undersøgelsesprodukt. Forsøgspersoner vil blive randomiseret til en af ​​to undersøgelsesarme; 1) en enkelt infusion af 6,0x106 celler/kg ved baseline, efterfulgt af en blindet placebo-infusion efter seks måneder eller 2) Placebo-infusion ved baseline, efterfulgt af en intravenøs dosis på 6x106 celler/kg efter seks måneder.

Det primære endepunkt for denne undersøgelse er ændringen i social kommunikationsfærdighed fra baseline til seks måneder. De potentielle risici forbundet med infusion af MSC'er omfatter en reaktion på produktet (udslæt, åndenød, hvæsende vejrtrækning, åndedrætsbesvær, hypotension, hævelse omkring mund, hals eller øjne, takykardi, diaforese), overførsel af infektion og HLA-sensibilisering.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

137

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • North Carolina
      • Durham, North Carolina, Forenede Stater, 27705
        • Duke University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

4 år til 11 år (Barn)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier

  1. Alder ≥ 4 år til < 12 år (11 år, 364 dage) på tidspunktet for samtykke
  2. Bekræftet klinisk DSM-5-diagnose af autismespektrumforstyrrelse ved hjælp af DSM-5-tjeklisten som informeret af Brief Observation of Symptoms of Autism (BOSA) og Autism Diagnostic Interview-Revised (ADI-R)
  3. Fragil X-test udført og negativ; CMA og/eller hel exome-sekventering udført og resultater, der ikke er knyttet til autismediagnose
  4. Stabil på nuværende psykiatrisk medicinbehandling (dosis og doseringsplan) i mindst 2 måneder før infusion af undersøgelsesprodukt
  5. Normalt absolut lymfocyttal (≥1200/uL for afroamerikanske deltagere og ≥1500/uL for alle andre deltagere)
  6. GAI ≥ 65 via kognitiv test af undersøgelsespersonale
  7. Deltager og forældre/værge taler engelsk
  8. I stand til at rejse til Duke University to gange (baseline, seks måneder), og forælder/værge er i stand til at deltage i foreløbige undersøgelser og interviews
  9. Forældre/værges samtykke fra mindst én forælder/værge

Eksklusionskriterier

  1. Generel:

    1. Gennemgang af journaler og/eller screeningsvurderinger indikerer ASD-diagnose og/eller GAI > 65 usikker
    2. Kendt diagnose af en af ​​følgende sameksisterende psykiatriske tilstande: depression, bipolar lidelse, skizofreni, obsessiv-kompulsiv lidelse forbundet med bipolar lidelse, Tourettes syndrom
    3. Screeningsdata tyder på, at deltageren ikke ville være i stand til at overholde kravene i undersøgelsesprocedurerne som vurderet af undersøgelsesholdet
    4. Familien er uvillig eller ude af stand til at forpligte sig til at deltage i alle undersøgelsesrelaterede vurderinger, inklusive protokolopfølgning
    5. Søskende er tilmeldt denne (Duke IMPACT) undersøgelse

  2. Genetisk:

    1. Optegnelser viser, at barnet har et kendt genetisk syndrom såsom (men ikke begrænset til) Fragilt X-syndrom, neurofibromatose, Rett-syndrom, tuberøs sklerose, PTEN-mutation, cystisk fibrose, muskeldystrofi eller en genetisk defekt, der definitivt vides at være forbundet med ASD
    2. Kendt patogen mutation eller kopiantal variation (CNV) forbundet med ASD (f.eks. 16p11.2, 15q13.2, 2q13.3)

  3. Smitsom:

    1. Kendt aktiv CNS-infektion
    2. Bevis for ukontrolleret infektion baseret på optegnelser eller klinisk vurdering
    3. Kendt HIV-positivitet
    4. Eksponering for COVID-19 i de foregående 14 dage eller positiv COVID-19-test i de foregående 28 dage. Forsøgspersoner med en tidligere historie med infektion med COVID-19 skal være symptomfri i 14 dage før det første besøg.

  4. Medicinsk:

    1. Kendt stofskiftesygdom
    2. Kendt mitokondriel dysfunktion
    3. Anamnese med ustabil epilepsi eller ukontrolleret anfaldssygdom, infantile spasmer, Lennox Gastaut syndrom, Dravet syndrom eller anden lignende kronisk anfaldssygdom
    4. Aktiv malignitet eller tidligere malignitet, der blev behandlet med kemoterapi
    5. Anamnese med en primær immundefektsygdom
    6. Anamnese med autoimmune cytopenier (dvs. ITP, AIHA)
    7. Sameksisterende medicinsk tilstand, der ville sætte barnet i øget risiko for komplikationer af undersøgelsesprocedurer
    8. Samtidig genetisk eller erhvervet sygdom eller komorbiditet(er), der kan kræve en fremtidig stamcelletransplantation
    9. Betydelig sensorisk (f.eks. blindhed, døvhed, ukorrigeret hørenedsættelse) eller motorisk (f.eks. cerebral parese) svækkelse
    10. Nedsat nyre- eller leverfunktion som bestemt af serumkreatinin >1,5 mg/dL eller total bilirubin >1,3 mg/dL, undtagen hos patienter med kendt Gilberts sygdom
    11. Signifikante hæmatologiske abnormiteter defineret som: Hæmoglobin <10,0 g/dL, blodplader <150 x 10e9/uL, WBC <3.000 celler/mL, ALC <1200/uL for afroamerikanere eller <1500/uL for alle andre deltagere.
    12. Evidens for klinisk relevant fysisk dysmorfologi, der indikerer et genetisk syndrom, vurderet af PI'erne eller andre efterforskere, herunder en medicinsk genetiker og psykiatere, der er uddannet i at identificere dysmorfe træk forbundet med neuroudviklingstilstande.

  5. Nuværende/tidligere terapi:

    en. Tilgængeligheden af ​​en banket, kvalificeret autolog navlestrengsblodsenhed eller forældre udskudt brug af kvalificeret, autolog navlestrengsblodsenhed b. Historie om tidligere celleterapi c. Nuværende eller tidligere brug af IVIG eller anden antiinflammatorisk medicin med undtagelse af NSAID'er d. Nuværende eller tidligere immunsuppressiv terapi i. Ingen systemisk steroidbehandling, der har varet >2 uger, og ingen systemiske steroider inden for 3 måneder før indskrivning. Aktuelle og inhalerede steroider er tilladt.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: MSC
En dosis på 6x10e6 celler/kg administreret intravenøst.
Biologisk: Mesenkymale stromale celler i ledningsvæv
Humane navlestrengsvæv afledte mesenkymale stromaceller (hCT-MSC), isoleret og ekspanderet fra navlestrengsvæv fra allogene ikke-relaterede donorer. En dosis på 6x10e6 celler/kg administreret intravenøst.
Placebo komparator: Placebo infusion
Andet: Placebo infusion
Placebo sammenlignende infusion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change on the Average Socialization and Communication Subscale Standard Scores on the Vineland Behavior Scales (VABS-3)
Tidsramme: Baseline, 6 months
The primary outcome measure is the mean of the Socialization and Communication Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form. The primary endpoint is the change in this outcome measure from baseline to six months before the second infusion. A positive change in the scores indicates an improvement in socialization and communication. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in VABS-3 (Vineland Adaptive Behavior Scales) Socialization Standard Score
Tidsramme: Baseline, 6 months
The change in the Socialization Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from baseline to six months. Higher Socialization Standard scores indicate greater socialization. A positive change in the scores indicates an improvement in socialization. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 Communication Standard Score
Tidsramme: Baseline, 6 months
The change in the Communication Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form from baseline to six months before the second infusion. Higher scores indicate greater communication. A positive change in the scores indicates an improvement in communication. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
CGI-S (Clinical Global Impression - Severity of Illness) Overall Score
Tidsramme: 6 months
The CGI-S Overall Score is a 7-point scale that requires the clinician to rate the severity of the participant's overall functioning and symptoms of autism at the time of assessment, relative to the clinician's experience with participants who have the same diagnosis. The clinician rates the severity of autism symptoms - 1, normal, no symptoms; 2, borderline level of symptoms; 3, mild symptoms; 4, moderate symptoms; 5, marked symptoms; 6, severe symptoms; or 7, extremely severe symptoms. The higher ratings indicate greater severity of overall functioning impairment.
6 months
CGI-I (Clinical Global Impression - Improvement) Overall Score
Tidsramme: 6 months
The CGI-I Overall Score is a 7-point scale that requires the clinician to assess how much the participant's autism overall functioning and symptoms have improved or worsened relative to a baseline assessment. The symptoms are rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. The lower scores indicate greater improvement.
6 months
Change in the Pediatric Quality of Life (PedsQL) Total Scale Score
Tidsramme: Baseline, 6 months
The PedsQL 4.0 Generic Core Scales is a 5-minute parent questionnaire that measures the child's functioning in the dimensions of physical, emotional, social, and school. The items use a Likert rating scale from 0 (Never) to 4 (Almost Always). This 0-4 scale is then transformed to 0=100, 1=75, 2=50, 3=25, and 4=0 for a reverse score. The Total Scale Score is then computed as the sum of all the items over the number of items answered on all the Scales for a total score range of 0 to 100. Higher scores indicate a better quality of life.
Baseline, 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants Experiencing an Infusion Reaction
Tidsramme: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not what they were randomized. Patients received the infusion to which they were randomized at baseline and the alternate treatment at 6 months. Therefore, adverse events are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion).
up to 12 months
Number of Participants Experiencing Product-related Infections
Tidsramme: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Evidence of Formation of Anti-HLA Antibodies
Tidsramme: Baseline, 6 months, 12 months
Assess for anti-HLA antibodies
Baseline, 6 months, 12 months
Number of Participants Experiencing Graft Versus Host Disease (GVHD)
Tidsramme: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Number of Participants Experiencing Unexpected Adverse Events Related to the Study Product
Tidsramme: up to 12 months
To assess safety, participants were considered according to the treatment received at each time point, not to what they were randomized. Patients received the infusion to which they are randomized at baseline, and the alternate treatment at 6 months. AEs are reported by randomized treatment arm broken into periods: 0-6 months (post-baseline infusion, pre-six month infusion) and 6-12 months (post-six month infusion). 6-12 month evaluation time points are further broken into whether or not the participant received a second infusion, since three MSC patients and one Placebo patient did not receive the 6-month incentive infusion but were still evaluated.
up to 12 months
Change on the Adaptive Behavior Composite Subscale Standard Score on the Vineland Behavior Scales (VABS-3)
Tidsramme: Baseline, 6 months
The change in the Vineland Adaptive Behavior Scales (VABS-3) Adaptive Behavior Composite Subscale from baseline to 6 months before the second infusion. Higher Adaptive Behavior Composite Standard scores indicate greater adaptive behavior. A positive change in the scores indicates an improvement in adaptive behavior. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 (Vineland Adaptive Behavior Scales) Daily Living Skills Standard Score
Tidsramme: Baseline, 6 months
The change in the Daily Living Skills Subscale Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from baseline to six months before the second infusion. Higher Daily Living Skills Standard scores indicate greater daily living skills. A positive change in the scores indicates an improvement in daily living skills. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in VABS-3 Motor Skills Standard Score
Tidsramme: Baseline, 6 months
The change in the Motor Skills Standard Scores on the Vineland Adaptive Behavior Scales (VABS-3) from the Comprehensive Interview form from baseline to six months before the second infusion. Higher scores indicate greater motor skills. A positive change in the scores indicates an improvement in motor skills. A standard score of 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Domain scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers.
Baseline, 6 months
Change in Aberrant Behavior Checklist-Community (ABC-C) Social Withdrawal
Tidsramme: Baseline, 6 months
The change in the Aberrant Behavior Checklist-Community (ABC-C) Social Withdrawal scale from baseline to six months before the second infusion. Higher scores indicate greater problems with social withdrawal. A positive change in the scores indicates a worsening in social withdrawal. This scale has 16 items that are scored on a 4-point Likert scale: 0 = not a problem, 1 = slight problem, 2 = moderately serious problem, 3 = severe problem. The individual items are added together to calculate the Social Withdrawal scale score.
Baseline, 6 months
Change in Pervasive Developmental Disorder Behavior Inventory (PDDBI) Total Score
Tidsramme: Baseline, 6 months
The change in the Pervasive Developmental Disorder Behavior Inventory (PDDBI) from baseline to 6 months before the second infusion. The PDDBI is a measure of problem behaviors and social, language, and learning or memory skills of children who have been diagnosed with autism spectrum disorder. Raw scores are converted to T-scores. The T-score has a mean of 50 with a standard deviation of 10 points with a range of 10-100. Higher scores indicate greater behavioral issues and a positive change in score indicates worsening.
Baseline, 6 months
Change in the Autism Impact Measure (AIM)
Tidsramme: Baseline, 6 months
The change in the Autism Impact Measure (AIM) from baseline to 6 months before second infusion. AIM is a measure of core Autism Spectrum Disorder Symptoms. It is a parent-report questionnaire that includes 41 core-symptom items rated on two corresponding 5-point scales: frequency (ranging from "never" to "always") and impact (ranging from "not at all" to "severely") over the previous two weeks. Frequency and impact ratings are combined, yielding a total score range of 82 to 410. Higher scores indicate greater symptom severity; a positive change in score indicates worsening of symptoms.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Emotional Control Subscale
Tidsramme: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Emotional Control subscale from baseline to month 6 before the second infusion. BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Working Memory Subscale
Tidsramme: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Working Memory subscale from baseline to month 6 before the second infusion. The BREIF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Inhibit Subscale
Tidsramme: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Inhibit subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Plan/Organization Subscale
Tidsramme: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Plan/Organization subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Behavior Rating Inventory of Executive Function (BRIEF) Shift Subscale
Tidsramme: Baseline, 6 months
The change in the Behavior Rating Inventory of Executive Function (BRIEF) Shift subscale from baseline to month 6 before the second infusion. The BRIEF is a survey that assesses executive function and self-regulation with the following subscales: Inhibit, Shift, Emotional Control, Working Memory, and Planning and Organization. Higher scores indicate greater levels of dysfunction each respective domain. A positive change in score indicates worsening the respective domain. Raw scores for each domain are converted to t-scores (Mean = 50, SD = 10) and percentiles. T scores 60-64 are considered to be mildly elevated, 65-69 are considered to be potentially clinically elevated, and >= 70 are considered to be clinically elevated.
Baseline, 6 months
Change in the Expressive Vocabulary Test (Third Edition, EVT-3)
Tidsramme: Baseline, 6 months
The change in the Expressive Vocabulary Test (Third Edition, EVT-3) from baseline to 6 months before the second infusion. The EVT-3 is a measure of a participant's ability to match a spoken word with an image of an object, action, or concept. The number of words that are retrieved is converted to a Standard Score, where 100 is the mean with a standard deviation of 15 points. A score of 100 should be understood as being similar to the typical population of the same age. Scores greater than or equal to 86 are considered adequate or above adequate. Scores less than or equal to 85 are considered moderately low to low and indicate the patient has a significant skill deficit when compared with similarly aged peers. A positive change in EVT-3 score indicates improvement.
Baseline, 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Joanne Kurtzberg, MD

Samarbejdspartnere

The Marcus Foundation
Cryo-Cell International

Efterforskere

  • Ledende efterforsker: Lauren Franz, MBChB, Duke University
  • Ledende efterforsker: Beth Shaz, MD, Duke University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. oktober 2020

Primær færdiggørelse (Faktiske)

2. maj 2023

Studieafslutning (Faktiske)

1. februar 2024

Datoer for studieregistrering

Først indsendt

12. september 2019

Først indsendt, der opfyldte QC-kriterier

12. september 2019

Først opslået (Faktiske)

13. september 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Pro00113011
  • Pro00102894 (Anden identifikator: Duke IRB)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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