Russian Kogenate Pediatric Study
4. juni 2015 opdateret af: Bayer
A Prospective Study to Evaluate the Effect of rFVIII-FS in Different Prophylactic Regimens on Bleeding Events Frequency and Development of Arthropathy in Previously Treated and Minimally Treated Hemophilia A Pediatric Population.
A prospective study to evaluate the effect of rFVIII-FS in different prophylactic regimens on bleeding events frequency and development of arthropathy in Previously Treated and Minimally treated Hemophilia A pediatric population.
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
32
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ekaterinburg, Den Russiske Føderation, 620149
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Kirov, Den Russiske Føderation, 610 027
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Moscow, Den Russiske Føderation, 105077
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St. Petersburg, Den Russiske Føderation, 191186
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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
1 år til 12 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Male
- Severe hemophilia A or moderate hemophilia A
- 1-12 years of age
- Requiring treatment with FVIII
Exclusion Criteria:
- Current or prior inhibitor or familial antecedents of inhibitor
- Surgery required during the study (9 months)
- Positive for HIV
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: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: rFVIII-FS (Kogenate FS, BAY14-2222), 70 IU/kg qw
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week [qw] (weekly on Day 7 + 1 after previous injection) for 9 months.
Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
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rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection once per week (weekly on Day 7 + 1 after previous injection) for 9 months.
Dose escalation was permitted due to joint bleeding (escalation to 35 IU/kg twice a week or further escalation to 25 IU/kg three times a week)
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Eksperimentel: rFVIII-FS (Kogenate FS, BAY14-2222), biw (30 IU/kg + 40 IU/kg)
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week [biw] (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months.
Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
|
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 70 IU/kg, dosing by injection twice per week (30 IU/kg [day 1] + 40 IU/kg [day 4]) for 9 months.
Dose escalation was permitted due to joint bleeding (escalation to 25 IU/kg three times a week)
|
|
Eksperimentel: rFVIII-FS (Kogenate FS, BAY14-2222), tiw (3 x 25 IU/kg)
rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week [tiw] (3 x 25 IU/kg [day 1, 3, 5]) for 9 months.
No escalation opportunity for participants in this group
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rFVIII-FS (Octocog-alfa, antihemophilic factor [recombinant]) 75 IU/kg, dosing by injection three times per week (3 x 25 IU/kg [day 1, 3, 5]) for 9 months.
No escalation opportunity for patients in this group
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Percentage of Participants With Less Than 2 Joint Bleeds During the 9-month Treatment Period
Tidsramme: Up to 9 months
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Up to 9 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Bleeds Per Participant During the 9-month Treatment Period
Tidsramme: Up to 9 months
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Up to 9 months
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Number of Participants With Bleeding Events During the 9-month Treatment Period
Tidsramme: Up to 9 months
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Up to 9 months
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Number of Participants With Joint Bleeds During the 9-month Treatment Period
Tidsramme: Up to 9 months
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Up to 9 months
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Number of Participants in Each Group at the End of the Study
Tidsramme: Up to 9 months
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Up to 9 months
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Actual Monthly rFVIII-FS Consumption
Tidsramme: Up to 9 months
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Up to 9 months
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Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment
Tidsramme: baseline and 9 months
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The assessment of joint function using Stockholm Joint Score.
The minimum value is 0 (the best condition), and the maximum value is 140 (the worst condition).
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baseline and 9 months
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Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)
Tidsramme: 9 months
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Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).
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9 months
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Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment
Tidsramme: 9 months
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Quality of life (QoL) was measured by the Haemo-QoL standardized total Score, which ranged from 0 (the best condition) to 100 (the worst condition).
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9 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
- V.V. Vdovin, T.A. Andreeva, T.A. Chernova, F.G. Perina, E.E.M. Shiller, P.V. Svirin, M. Maas Enriquez, and S. Rauchensteiner. Prophylaxis with Once, Twice or Three-Times Weekly Dosing of rFVIII-FS Prevents Joint Bleeds in a Previously Treated Pediatric Population with Moderate/Severe Hemophilia A. Journal of Coagulation Disorders 2011; 3:(1). October 2011
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
1. juni 2007
Primær færdiggørelse (Faktiske)
1. september 2009
Studieafslutning (Faktiske)
1. september 2009
Datoer for studieregistrering
Først indsendt
4. marts 2008
Først indsendt, der opfyldte QC-kriterier
10. marts 2008
Først opslået (Skøn)
11. marts 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
1. juli 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 12684
- 2014-005253-39 (EudraCT nummer)
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 .