Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Et klinisk forsøg med undersøgelse af medicin (Marstacimab) hos pædiatriske patienter med hæmofili A eller hæmofili B (BASIS KIDS)

8. oktober 2026 opdateret af: Pfizer

En åben-label undersøgelse i pædiatri (

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called marstacimab) for the potential treatment of hemophilia in pediatric patients.

This study will enroll pediatric participants from ages 1 to 17 years in a sequential manner. The study opened the enrollment to adolescent participants aged 12 to 17 years first. Then children aged 6 to 11 years erere permitted to enroll. Lastly, children aged 1 to 5 years are permitted to enroll.

This study will enroll male participants who:

  • have severe Hemophilia A or moderately severe to severe Hemophilia B (with or without inhibitors)
  • have accurate historical records documenting all factor VIII, factor IX, or bypass agent infusions and hemophilia bleed events for at least 1 year prior to entering the study for participants from 6 to 17 years of age, and at least 3 months prior to entering the study for participants from 1 to 5 years of age
  • if a non-inhibitor patient, must be on a stable routine prophylaxis regimen with factor VIII or factor IX replacement products for at least 12 months prior to study entry for participants from 6 to 17 years of age, and least 3 months for participants aged from 1 to 5 years of age
  • if an inhibitor patient, must be on an on-demand bypass treatment regimen during the 12 months prior to study entry for participants from 6 to 17 years of age, and during the 3 months prior to study entry for participants aged from 1 to 5 years of age

All participants in this study will receive marstacimab to use prophylactically. Marstacimab will be given once a week as a subcutaneous (under the skin) shot. The first dose of marstacimab will be given at the study site by the study site staff. During the 12-month treatment period, weekly doses of marstacimab can be given at home, or if preferred, the doses may be given by the study site staff.

To help us determine if the study medicine is safe and effective, we will compare participant experiences when they are taking the study medicine to a historical period when they were not. Researchers want to see if the study medicine works to prevent the bleeding episodes commonly experienced by patients with Hemophilia.

Participants will be in this study for about 14 months (approximately 1 month in a Screening period, 12 months receiving treatment, and 1 month in a follow-up period) during which they will visit the study site at least 10 times. If preferred, and if local regulations allow it, 2 of the study visits can be completed at the participant's home instead of at the study site. There will also be 6 scheduled telephone calls approximately every 2 months.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Fase 3

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Argentina
    • Mendoza Province
      • Mendoza, Mendoza Province, Argentina, M5501
        • Rekruttering
        • Arbesu Hematología
  • Australien
      • Parkville, Australien, 3052
        • Rekruttering
        • Murdoch Children's Research Institute
  • Brasilien
    • VITÓRIA
      • Maruípe, VITÓRIA, Brasilien, 29047-105
        • Aktiv, ikke rekrutterende
        • Centro Estadual de Hemoterapia e Hematologia Marcos Daniel Santos - HEMOES
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Aktiv, ikke rekrutterende
        • Stollery Children's Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Aktiv, ikke rekrutterende
        • Hamilton Health Sciences - McMaster University/McMaster Children's Hospital
  • Danmark
      • Aarhus N, Danmark, 8200
        • Rekruttering
        • Aarhus Universitetshospital, Skejby
    • Aarhus N
      • Aarhus N, Aarhus N, Danmark, DK-8200
        • Rekruttering
        • Aarhus University
    • Capital Region
      • Copenhagen, Capital Region, Danmark, 2100
        • Rekruttering
        • Rigshospitalet
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B4 6NH
        • Rekruttering
        • Birmingham Children's Hospital
      • London, Det Forenede Kongerige, SE1 7EH
        • Rekruttering
        • Evelina London Children's Hospital
      • Manchester, Det Forenede Kongerige, M13 9WL
        • Afsluttet
        • Royal Manchester Children's Hospital
      • Newcastle upon Tyne, Det Forenede Kongerige, NE7 7DN
        • Rekruttering
        • Freeman Hospital
    • England
      • Newcastle upon Tyne, England, Det Forenede Kongerige, NE1 4LP
        • Rekruttering
        • Royal Victoria Infirmary
  • Forenede Stater
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84113
        • Rekruttering
        • Intermountain - Primary Children's Hospital
  • Indien
    • Gujarat
      • Surat, Gujarat, Indien, 395002
        • Rekruttering
        • Nirmal Hospital Pvt Ltd.
    • Maharashtra
      • Mumbai, Maharashtra, Indien, 400022
        • Rekruttering
        • K. J. Somaiya Hospital and Research Centre, Somaiya Ayurvihar Complex
    • West Bengal
      • Kolkata, West Bengal, Indien, 700014
        • Rekruttering
        • Nil Ratan Sircar Medical College and Hospital
  • Israel
    • Central District
      • Ramat Gan, Central District, Israel, 5262100
        • Rekruttering
        • Sheba Medical Center
  • Italien
    • Liguria
      • Genoa, Liguria, Italien, 16147
        • Rekruttering
        • IRCCS Istituto Giannina Gaslini
    • Milan
      • Rozzano, Milan, Italien, 20089
        • Rekruttering
        • Istituto Clinico Humanitas - Humanitas Mirasole SPA
    • PARMA
      • Parma, PARMA, Italien, 43126
        • Rekruttering
        • Azienda Ospedaliero Universitaria di Parma
    • ROMA
      • Rome, ROMA, Italien, 00165
        • Rekruttering
        • Ospedale Pediatrico Bambino Gesù IRCCS
    • TORINO
      • Torino, TORINO, Italien, 10126
        • Rekruttering
        • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
  • Japan
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Rekruttering
        • Hyogo prefectural Kobe Children's Hospital
    • Nagano
      • Azumino, Nagano, Japan, 399-8288
        • Aktiv, ikke rekrutterende
        • Nagano Children's Hospital
    • Nara
      • Kashihara, Nara, Japan, 634-8522
        • Rekruttering
        • Nara Medical University Hospital
    • Saga-ken
      • Saga, Saga-ken, Japan, 849-8501
        • Aktiv, ikke rekrutterende
        • Saga University Hospital
    • Saitama
      • Saitama-shi, Saitama, Japan, 330-8777
        • Rekruttering
        • Saitama Prefectural Children's Medical Center
  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100045
        • Rekruttering
        • Beijing Children's hospital, Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510515
        • Aktiv, ikke rekrutterende
        • Southern Medical University Nanfang Hospital
    • Guizhou
      • Guiyang, Guizhou, Kina, 550004
        • Aktiv, ikke rekrutterende
        • The Affiliated Hospital of Guizhou Medical University
    • Hubei
      • Wuhan, Hubei, Kina, 430030
        • Rekruttering
        • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
      • Wuhan, Hubei, Kina, 430030
        • Rekruttering
        • Tongji Hospital of Tongji Medical College of HUST/Pediatric Hematology Department Pharmacy
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Aktiv, ikke rekrutterende
        • Jiangxi Provincial People's Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina
        • Rekruttering
        • Institute of hematology&blood disease hospital
  • Mexico
    • Veracruz
      • Veracruz, Veracruz, Mexico, 91900
        • Rekruttering
        • Arké SMO S.A de C.V
  • Saudi Arabien
    • Dammam
      • Dammam, Dammam, Saudi Arabien, 32253
        • Aktiv, ikke rekrutterende
        • King Fahad Specialist Hospital
  • Slovakiet
      • Košice, Slovakiet, 040 11
        • Rekruttering
        • Detska fakultna nemocnica Kosice
      • Martin, Slovakiet, 036 59
        • Rekruttering
        • Univerzitna nemocnica Martin
  • Spanien
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spanien, 28046
        • Rekruttering
        • Hospital Universitario La Paz
    • ZARAGOZA
      • Zaragoza, ZARAGOZA, Spanien, 50009
        • Rekruttering
        • Hospital Universitario Miguel Servet
  • Sydafrika
    • Gauteng
      • Benoni, Gauteng, Sydafrika, 1500
        • Aktiv, ikke rekrutterende
        • Worthwhile Clinical Trials
      • Johannesburg, Gauteng, Sydafrika, 2193
        • Aktiv, ikke rekrutterende
        • Charlotte Maxeke Johannesburg Academic Hospital
  • Sydkorea
    • Seoul-teukbyeolsi [seoul]
      • Seoul, Seoul-teukbyeolsi [seoul], Sydkorea, 03722
        • Rekruttering
        • Severance Hospital, Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [seoul], Sydkorea, 05278
        • Rekruttering
        • Kyung Hee University Hospital at Gangdong
    • Taegu-kwangyǒkshi
      • Daegu, Taegu-kwangyǒkshi, Sydkorea, 41944
        • Rekruttering
        • Kyungpook National University Hospital
  • Taiwan
      • Taichung, Taiwan, 407219
        • Rekruttering
        • Taichung Veterans General Hospital
      • Taipei, Taiwan, 100
        • Rekruttering
        • National Taiwan University Hospital
  • Tjekkiet
      • Brno, Tjekkiet, 625 00
        • Rekruttering
        • Fakultni nemocnice Brno
      • Prague, Tjekkiet, 150 00
        • Rekruttering
        • Fakultni Nemocnice Motol a Homolka
    • Brno-město
      • Brno, Brno-město, Tjekkiet, 613 00
        • Rekruttering
        • Detska nemocnice FN Brno
  • Tyrkiet (Türkiye)
      • Ankara, Tyrkiet (Türkiye), 06560
        • Rekruttering
        • Gazi University Health Research and Application Center Gazi Hospital
      • Izmir, Tyrkiet (Türkiye), 35010
        • Rekruttering
        • Ege University
    • Adana
      • Adana, Adana, Tyrkiet (Türkiye), 01130
        • Rekruttering
        • Adana Acibadem Hastanesi Pediatrik Hematoloji Bilim Dali
    • Ankara
      • Ankara, Ankara, Tyrkiet (Türkiye), 06500
        • Rekruttering
        • Gazi University Medical Faculty
      • Ankara, Ankara, Tyrkiet (Türkiye), 06560
        • Rekruttering
        • Gazi Universitesi Tip Fakultesi Hastanesi Cocuk Hematologi Bolumu
    • Istanbul
      • Istanbul, Istanbul, Tyrkiet (Türkiye), 34093
        • Rekruttering
        • Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
    • Kayseri
      • Kayseri, Kayseri, Tyrkiet (Türkiye), 38039
        • Rekruttering
        • Erciyes University Faculty of Medicine Pediatric
      • Melikgazi, Kayseri, Tyrkiet (Türkiye), 38039
        • Rekruttering
        • Erciyes University Health Application and Research Center Directorate
    • Samsun
      • Samsun, Samsun, Tyrkiet (Türkiye), 55200
        • Rekruttering
        • Ondokuz Mayıs Universitesi
    • İzmir
      • Izmir, İzmir, Tyrkiet (Türkiye), 35100
        • Rekruttering
        • Ege Universitesi Tip Fakultesi Hastanes
  • Tyskland
    • State of Berlin
      • Berlin, State of Berlin, Tyskland, 13353
        • Rekruttering
        • Charité Campus Virchow-Klinikum
  • Østrig
    • State of Vienna
      • Vienna, State of Vienna, Østrig, 1090
        • Rekruttering
        • Medizinische Universität Wien

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

1 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Male participants of appropriate age and required minimum weight
  • Participants aged 12 to 17 years must be at least 25 kgs at time of consent.
  • Participants aged 6 to 11 years must be at least 19 kgs at time of consent.
  • Participants aged 1 to 5 years must be at least 5 kgs at time of consent.
  • Participants with a diagnosis of severe hemophilia A or moderately severe to severe hemophilia B
  • Participants must have at least 1 year (if aged 6 to 17 years), or at least 3 months (if aged 1 to 5 years) of diary and/or medical records available in which exogenous FVIII or FIX replacement or bypass agent infusions and hemophilic bleeding episodes were consistently documented over over the above specified timeframe to the time of consent.

Participants who are enrolled into the Non-Inhibitor Cohort must also meet the following criteria:

  • No current detectable inhibitor and no documented history of inhibitors in the 5 years prior to consent
  • Must have at least 50 exposure days to FVIII/FIX replacement products for participants aged 6 to 17 years. Participants from 1 to 5 years do not require a minimum documented number of exposure days
  • Must be at least 80% compliant with a stable and effective routine prophylaxis regimen with FVIII/FIX replacement products, for at least 12 months prior to consent for participants aged 6 to 17 years, for at least 3 months prior to consent for participants from 1 to 5 years

Participants who are enrolled into the Inhibitor Cohort must also meet the following criteria:

  • Documentation of current high titer inhibitor (≥5 BU/mL); or current low titer inhibitor (<5 BU/mL) refractory to FVIII or FIX replacement and with FVIII or FIX recovery <60% of expected within previous 12 months prior to the time of consent
  • Participants who have documented inhibitors while on factor-replacement therapy but who do not meet the high quantitative inhibitor criteria described in the prior bullet at the time of screening (eg, participant with a previously documented high-titer inhibitor ≥5 BU/mL) and whose condition precludes re-challenge with FVIII or FIX replacement may be considered for eligibility on a case-by-case basis with discussion and agreement from the Pfizer medical monitor.
  • Participants aged 6 to 17 years: Hemophilia A participants with on-demand treatment regimen with ≥12 bleeding episodes or hemophilia B participants with on-demand treatment regimen with ≥8 bleeding episodes (spontaneous or traumatic) necessitating treatment with bypass factor in the 12 months prior to informed consent
  • Participants aged 1 to 5 years of age with at least 3 months' on-demand bypass treatment regimen and at least 1 treated hemophilic bleeding in the last 3 months or at least 2 treated hemophilic bleedings in the last 6 months documented prior to the time of informed consent
  • Participants aged 6 to 17 years must be on an on-demand bypass treatment regimen during the 12 months prior to informed consent
  • Participants aged 1 to 5 years of age must be on an on-demand bypass treatment regimen during the 3 months prior to informed consent

Exclusion Criteria:

  • Known coronary artery, thrombotic, or ischemic disease, or current evidence of congenital or acquired thrombophilic disease such as Anti-thrombin III deficiency, Factor V Leiden mutation, prothrombin 20210 mutation, protein C deficiency, protein S deficiency and antiphospholipid syndrome.
  • Known planned surgical procedure during the planned study period
  • Known hemostatic defect other than hemophilia A or B
  • Abnormal hematology, renal or hepatic function laboratory results at screening
  • Current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice, or cirrhosis. Participants aged 1 to 5 years with known hepatitis B or C will also be excluded
  • Known HIV-positive for participants aged 1 to 5 years of age
  • Other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator
  • Individuals with known allergic reaction or hypersensitivity to hamster protein or other components of the study intervention
  • Current routine prophylaxis with bypassing agent, non-coagulation non-factor replacement therapy (eg, emicizumab), or any previous treatment with a gene therapy product for treatment of hemophilia
  • Participants with inhibitors who are being treated using a prophylaxis treatment regimen with a bypass agent, and, participants who have previously received non-factor-based hemophilia therapy (eg, fitusiran, concizumab, emicizumab) will be considered on a case-by-case basis, only after discussion and agreement between the investigator and the Pfizer medical monitor
  • Regular use of immunomodulatory medications (eg, IVIG, routine systemic corticosteroids, rituximab)
  • Use of systemic antifibrinolytics, medications that may increase the risk of bleeding, and certain non-steroidal anti-inflammatory drugs within 120 hours of first dose of study intervention and while on study. Some of these agents may be permitted if it is authorized for use in the respective country, is part of the standard of care in the study population, its use is short term and on a PRN basis and following discussion with the Pfizer medical monitor.
  • Ongoing or planned use of ITI, or prophylaxis with FVIII or FIX replacement at any time after initiation of treatment with study intervention
  • Participation in other studies involving investigational drug(s) or investigational vaccine(s) within 30 days (or as determined by local requirements) or 5 half-lives prior to study entry or during study participation
  • Previous exposure to marstacimab during participation in other marstacimab clinical studies
  • CD4 cell count ≤200/uL if HIV-positive, for participants aged 6 to 17 years
  • Abnormal ECG of clinical relevance that may affect participant safety or interpretation of study results
  • Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members

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: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: marstacimab (PF-06741086)

Weekly subcutaneous injections.
Medicin: marstacimab

marstacimab

Andre navne:
  • PF-06741086

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forekomst af uønskede hændelser og alvorlige bivirkninger
Tidsramme: Screening til slutningen af ​​opfølgningsperioden (ca. 14 måneder)
Screening til slutningen af ​​opfølgningsperioden (ca. 14 måneder)
Hyppighed og sværhedsgrad af trombotiske hændelser
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Hyppighed og sværhedsgrad af trombotisk mikroangiopati
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Hyppighed og sværhedsgrad af dissemineret intravaskulær koagulation/forbrugskoagulopati hændelser
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Immunogenicitet (forekomst af ADA og klinisk signifikant persistent NAb mod marstacimab)
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Hyppighed og sværhedsgrad af reaktioner på injektionsstedet
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Forekomst af svær overfølsomhed og anafylaktiske reaktioner
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Annualized bleeding rate (ABR) of treated bleeding events
Tidsramme: Baseline (up to 12 months prior to informed consent) to the end of the 12-month treatment period

Derived for each subject for each period (historical and study treatment) by using the following formula: ABR = number of bleeds requiring treatments/ (days on treatment period / 365.25)
Baseline (up to 12 months prior to informed consent) to the end of the 12-month treatment period

Sekundære resultatmål

Resultatmål
Tidsramme
Forekomst af ledblødninger (behandlet)
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Forekomst af spontane blødninger (behandlet)
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Forekomst af målledsblødninger (behandlet)
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Forekomst af totale blødninger (behandlede og ubehandlede)
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Antal målled
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Ændring fra baseline i ledsundhed som målt af HJHS for deltagere ≥4 år
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Ændringer i livskvalitet målt ved Haem-A-QoL/Haemo-QoL (ved brug af aldersafhængige versioner for deltagere ≥8 år)
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Ændringer i livskvalitet målt ved pedHAL (ved brug af aldersafhængige versioner for deltagere ≥4 år)
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Ændringer i livskvalitet målt ved Patient Global Impression of Change - Hæmofili for deltagere ≥4 år
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode
Ændringer i livskvalitet målt ved Health Utilities Measure (EQ-5D-Y) for deltagere ≥4 år
Tidsramme: Baseline til slutningen af ​​12-måneders behandlingsperiode
Baseline til slutningen af ​​12-måneders behandlingsperiode

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

Efterforskere

  • Studieleder: Pfizer CT.gov Call Center, Pfizer

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.

Hjælpsomme links

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)

9. december 2022

Primær færdiggørelse (Anslået)

10. september 2028

Studieafslutning (Anslået)

10. september 2028

Datoer for studieregistrering

Først indsendt

27. oktober 2022

Først indsendt, der opfyldte QC-kriterier

7. november 2022

Først opslået (Faktiske)

10. november 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • B7841008
  • 2022-500495-65-00 (Registry Identifier: CTIS (EU))
  • ANTI-TFPI PEDIATRIC STUDY (Anden identifikator: Alias Study Number)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

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 .

Abonner