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hCT-MSC hos barn med autismespektrumforstyrrelse (IMPACT)

28. mai 2026 oppdatert av: Joanne Kurtzberg, MD

En fase II-studie av hCT-MSC, et navlestreng-avledet mesenkymalt stromalcelleprodukt, hos barn med autismespektrumforstyrrelse

Hensikten med denne fase II-studien er å bestemme effekten av humane navlestrengsvevsavledede mesenkymale stromaceller (hCT-MSC) for å forbedre sosiale kommunikasjonsevner hos barn med autismespektrumforstyrrelse (ASD).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Hensikten med denne dobbeltblindede fase II-studien er å bestemme effekten av humane navlestrengsvevsavledede mesencymale stromaceller (hCT-MSC), administrert i to forskjellige doseringsstrategier, hos barn med autismespektrumforstyrrelse (ASD).

Denne studien vil omfatte barn med ASD i alderen 4-11 år. Kvalifiserte emner vil gjennomgå nevropsykologisk evaluering, EEG-testing, øyesporing, CVA-vurderinger og infusjon av studieprodukt. Forsøkspersoner vil bli randomisert til en av to studiearmer; 1) en enkelt infusjon av 6,0x106 celler/kg ved baseline, etterfulgt av en blindet placebo-infusjon ved seks måneder eller, 2) Placebo-infusjon ved baseline, etterfulgt av en intravenøs dose på 6x106 celler/kg etter seks måneder.

Det primære endepunktet for denne studien er endringen i sosial kommunikasjonsevne fra baseline til seks måneder. Den potensielle risikoen forbundet med infusjon av MSC inkluderer en reaksjon på produktet (utslett, kortpustethet, hvesing, pustevansker, hypotensjon, hevelse rundt munnen, halsen eller øynene, takykardi, diaforese), overføring av infeksjon og HLA-sensibilisering.

Studietype

Intervensjonell

Registrering (Faktiske)

137

Fase

  • Fase 2

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • North Carolina
      • Durham, North Carolina, Forente stater, 27705
        • Duke University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 år til 11 år (Barn)

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier

  1. Alder ≥ 4 år til < 12 år (11 år, 364 dager) på tidspunktet for samtykke
  2. Bekreftet klinisk DSM-5-diagnose av autismespektrumforstyrrelse ved hjelp av DSM-5-sjekklisten som informert av Brief Observation of Symptoms of Autism (BOSA) og Autism Diagnostic Interview-Revised (ADI-R)
  3. Fragil X-testing utført og negativ; CMA og/eller hel exome-sekvensering utført og resultater ikke knyttet til autismediagnose
  4. Stabil på gjeldende psykiatrisk medisinregime (dose og doseringsplan) i minst 2 måneder før infusjon av studieproduktet
  5. Normalt absolutt lymfocyttantall (≥1200/uL for afroamerikanske deltakere og ≥1500/uL for alle andre deltakere)
  6. GAI ≥ 65 via kognitiv testing av studiepersonell
  7. Deltaker og foreldre/foresatte er engelsktalende
  8. Kan reise til Duke University to ganger (grunnlinje, seks måneder), og foreldre/foresatte kan delta i interimsundersøkelser og intervjuer
  9. Foreldre/foresatte samtykke fra minst én forelder/foresatt

Eksklusjonskriterier

  1. Generell:

    1. Gjennomgang av journaler og/eller screeningsvurderinger indikerer ASD-diagnose og/eller GAI > 65 usikker
    2. Kjent diagnose av noen av følgende psykiatriske tilstander samtidig: depresjon, bipolar lidelse, schizofreni, tvangslidelse assosiert med bipolar lidelse, Tourette syndrom
    3. Screeningsdata tyder på at deltakeren ikke ville være i stand til å overholde kravene til studieprosedyrene som er vurdert av studieteamet
    4. Familien er uvillig eller ute av stand til å forplikte seg til å delta i alle studierelaterte vurderinger, inkludert protokolloppfølging
    5. Søsken er påmeldt denne (Duke IMPACT) studien

  2. Genetisk:

    1. Registreringer indikerer at barnet har et kjent genetisk syndrom som (men ikke begrenset til) Fragilt X-syndrom, nevrofibromatose, Rett-syndrom, tuberøs sklerose, PTEN-mutasjon, cystisk fibrose, muskeldystrofi eller en genetisk defekt som definitivt er kjent for å være assosiert med ASD
    2. Kjent patogen mutasjon eller kopiantallvariasjon (CNV) assosiert med ASD (f.eks. 16p11.2, 15q13.2, 2q13.3)

  3. Smittsom:

    1. Kjent aktiv CNS-infeksjon
    2. Bevis på ukontrollert infeksjon basert på journaler eller klinisk vurdering
    3. Kjent HIV-positivitet
    4. Eksponering for covid-19 i løpet av de foregående 14 dagene eller positiv covid-19-test i løpet av de foregående 28 dagene. Personer med tidligere infeksjon med COVID-19 må være symptomfrie i 14 dager før det første besøket.

  4. Medisinsk:

    1. Kjent metabolsk forstyrrelse
    2. Kjent mitokondriell dysfunksjon
    3. Anamnese med ustabil epilepsi eller ukontrollert anfallsforstyrrelse, infantile spasmer, Lennox Gastaut syndrom, Dravet syndrom eller annen lignende kronisk anfallslidelse
    4. Aktiv malignitet eller tidligere malignitet som ble behandlet med kjemoterapi
    5. Historie om en primær immunsviktforstyrrelse
    6. Historie med autoimmune cytopenier (dvs. ITP, AIHA)
    7. Sameksisterende medisinsk tilstand som vil gi barnet økt risiko for komplikasjoner av studieprosedyrer
    8. Samtidig genetisk eller ervervet sykdom eller komorbiditet(er) som kan kreve en fremtidig stamcelletransplantasjon
    9. Betydelig sensorisk (f.eks. blindhet, døvhet, ukorrigert hørselshemming) eller motorisk (f.eks. cerebral parese) svekkelse
    10. Nedsatt nyre- eller leverfunksjon som bestemt av serumkreatinin >1,5 mg/dL eller total bilirubin >1,3 mg/dL, unntatt hos pasienter med kjent Gilberts sykdom
    11. Signifikante hematologiske abnormiteter definert som: Hemoglobin <10,0 g/dL, blodplater <150 x 10e9/uL, WBC <3000 celler/mL, ALC <1200/uL for afroamerikanere eller <1500/uL for alle andre deltakere.
    12. Bevis på klinisk relevant fysisk dysmorfologi som indikerer et genetisk syndrom, vurdert av PI-ene eller andre etterforskere, inkludert en medisinsk genetiker og psykiatere som er opplært i å identifisere dysmorfe trekk assosiert med nevroutviklingstilstander.

  5. Nåværende/tidligere terapi:

    en. Tilgjengelighet av en banket, kvalifisert autolog navlestrengsblodenhet eller foreldre utsatt bruk av kvalifisert, autolog navlestrengsblodenhet b. Historie om tidligere celleterapi c. Nåværende eller tidligere bruk av IVIG eller andre antiinflammatoriske medisiner med unntak av NSAIDs d. Nåværende eller tidligere immunsuppressiv terapi i. Ingen systemisk steroidbehandling som har vart >2 uker, og ingen systemiske steroider innen 3 måneder før registrering. Aktuelle og inhalerte steroider er tillatt.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: MSC
En dose på 6x10e6 celler/kg administrert intravenøst.
Biologisk: Mesenkymale stromale celler i ledningsvev
Humane navlestrengsvev avledet mesenkymale stromaceller (hCT-MSC), isolert og utvidet fra navlestrengsvev fra allogene urelaterte donorer. En dose på 6x10e6 celler/kg administrert intravenøst.
Placebo komparator: Placebo infusjon
Annen: Placebo infusjon
Placebo sammenlignende infusjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Joanne Kurtzberg, MD

Samarbeidspartnere

The Marcus Foundation
Cryo-Cell International

Etterforskere

  • Hovedetterforsker: Lauren Franz, MBChB, Duke University
  • Hovedetterforsker: Beth Shaz, MD, Duke University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. oktober 2020

Primær fullføring (Faktiske)

2. mai 2023

Studiet fullført (Faktiske)

1. februar 2024

Datoer for studieregistrering

Først innsendt

12. september 2019

Først innsendt som oppfylte QC-kriteriene

12. september 2019

Først lagt ut (Faktiske)

13. september 2019

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. mai 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Pro00113011
  • Pro00102894 (Annen identifikator: Duke IRB)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere