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Retrospective Study to Capture Dosing and Treatment Outcome Data in Participants With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND

7. april 2021 opdateret af: Baxalta now part of Shire

A Retrospective Study to Capture Dosing and Treatment Outcome Data in Subjects With Severe Congenital Protein C Deficiency Who Were Treated With Protein C Concentrate Under an Emergency Use IND

This is a data collection study with the purpose of capturing dosing and treatment outcome data in participants with severe congenital protein C deficiency who were treated with protein C concentrate under an Emergency Use Investigational New Drug Application (IND).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

11

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90027
        • Children´s Hospital of Los Angeles
    • Colorado
      • Denver, Colorado, Forenede Stater, 80218
        • Children´s Hospital Denver
      • Fort Carson, Colorado, Forenede Stater, 80973
        • Evans Army Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Children´s Hospital Boston
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Rainbow Babies & Children´s Hospital
      • Dayton, Ohio, Forenede Stater, 45404
        • The Children´s Medical Center - Dayton
    • Rhode Island
      • Providence, Rhode Island, Forenede Stater, 02903
        • Rhode Island Hospital
    • Texas
      • Fort Worth, Texas, Forenede Stater, 76104
        • Cook Children´s Medical Center
      • Galveston, Texas, Forenede Stater, 77555
        • University of Texas Medical Branch
      • Houston, Texas, Forenede Stater, 80218
        • Texas Children´s Hospital

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

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Participant treated with protein C concentrate under a Baxter Healthcare Corporation Emergency Use IND.
  • Participant with diagnosis of severe congenital protein C deficiency.
  • Participant or parent/legally authorized representative has provided written informed consent.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
All participants
Participants with severe congenital protein C deficiency who were treated under an emergency use IND.
Medicin: Protein C Concentrate (Human) Vapor Heated
Protein C Concentrate (Human) Vapor Heated

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Participants who Received a Dose of Protein C in Retrospective Study
Tidsramme: Throughout the study period (up to 6 months)
Number of participants who received a dose of Protein C in retrospective study will be reported.
Throughout the study period (up to 6 months)
Number of Participants with Prophylactic Treatment Outcome
Tidsramme: Throughout the study period (up to 6 months)
Participants experience any episodes of purpura fulminans (PF), coumarin induced skin necrosis (CISN), or thromboembolic event during prophylactic treatment will be assessed.
Throughout the study period (up to 6 months)
Number of Participants with Acute Episode Treatment Outcome
Tidsramme: Throughout the study period (up to 6 months)
Acute episode treatment outcome includes type of episode (PF, CISN, Thromboembolic); Was treatment effective or not effective; Was patient successfully transitioned to anticoagulation following the resolution of the episode will be assessed.
Throughout the study period (up to 6 months)
Number of Participants with Adverse Experiences (AEs) Related to Protein C Concentrate Treatment
Tidsramme: Throughout the study period (up to 6 months)
An AE is defined as any untoward medical occurrence in a participant administered study product that does not necessarily have a casual relationship with the treatment. AEs considered possibly or probably related to Protein C Concentrate treatment will be recorded on case report forms (CRFs).
Throughout the study period (up to 6 months)

Samarbejdspartnere og efterforskere

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

Sponsor

Baxalta now part of Shire

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)

1. juni 2005

Primær færdiggørelse (Faktiske)

1. december 2005

Studieafslutning (Faktiske)

1. december 2005

Datoer for studieregistrering

Først indsendt

8. september 2005

Først indsendt, der opfyldte QC-kriterier

8. september 2005

Først opslået (Skøn)

13. september 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. april 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. april 2021

Sidst verificeret

1. april 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 400501

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