- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02427217
An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency
12. januar 2018 opdateret af: CSL Behring
A Multicenter Study on the Retrospective Safety and Efficacy of Fibrinogen Concentrate (Human) (FCH) for Routine Prophylaxis, Treatment of Bleeding or Surgery in Subjects With Congenital Fibrinogen Deficiency With a Prospective Followup Component
This is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of FCH use in subjects with congenital fibrinogen deficiency.
Data will be collected on the safety and efficacy of FCH as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects.
All subjects have received FCH and may continue to receive FCH at the discretion of the treating physician / Primary Investigator according to the standard of care at the participating study site.
Studieoversigt
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
22
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Study Site
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Edmonton, Alberta, Canada, T6G 2H7
- Study Site
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0V9
- Study Site
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H2Y9
- Study Site
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Ontario
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Hamilton, Ontario, Canada, L8S 3Z5
- Study Site
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Toronto, Ontario, Canada, M5B 1W8
- Study Site
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Toronto, Ontario, Canada, M5G 1X8
- Study Site
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Quebec
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Montreal, Quebec, Canada, H3T 1C5
- Study Site
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Colorado
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Aurora, Colorado, Forenede Stater, 80045
- Study Site
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Nevada
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Las Vegas, Nevada, Forenede Stater, 89109
- Study Site
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North Carolina
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Durham, North Carolina, Forenede Stater, 27705
- Study Site
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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
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
Beskrivelse
Inclusion Criteria:
- Male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency.
- Have received FCH (Haemocomplettan® P or RiaSTAP®) for treatment of bleeding, surgery or prophylaxis.
Exclusion Criteria:
None
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: Andet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
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Fibrinogen Concentrate, Human (FCH)
A cohort of subjects who have retrospectively received FCH for the treatment of bleeding, routine prophylaxis and/or use in surgery, and who may continue to prospectively receive FCH at the discretion of the treating physician.
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FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma.
FCH is administered as an IV infusion.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Percentage of participants achieving hemostatic efficacy - retrospective
Tidsramme: From the subject's first use of FCH, up to approximately 20 years.
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The investigator's overall assessment of hemostatic efficacy of FCH from a review of the subject's historical records.
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From the subject's first use of FCH, up to approximately 20 years.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Percentage of participants achieving hemostatic efficacy - prospective
Tidsramme: Approximately 12 months
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The investigator's overall assessment of hemostatic efficacy of FCH during the prospective follow-up period.
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Approximately 12 months
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Percentage of participants with adverse events
Tidsramme: Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months.
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Retrospective data collection is from the subject's first use of FCH (up to approximately 20 years); Prospective data collection is from the time of informed consent up to approximately 12 months.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
7. maj 2015
Primær færdiggørelse (Faktiske)
6. december 2017
Studieafslutning (Faktiske)
6. december 2017
Datoer for studieregistrering
Først indsendt
22. april 2015
Først indsendt, der opfyldte QC-kriterier
22. april 2015
Først opslået (Skøn)
27. april 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. januar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
12. januar 2018
Sidst verificeret
1. januar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- BI3023_4003
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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