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Congenital Hemophilia A

Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A
NCT02093897 | PHASE 3 | INTERVENTIONAL

This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A. A minimum of 25 previously treated subjects ≥ 6 to \< 12 years of age and at least 25 subjects \< 6 years of age who have undergone \> 50 exposure days (EDs) with a previous Factor VIII (FVIII) product are planned to be enrolled. Subjects will be assigned to either an on-demand or prophylaxis treatment regimen and will receive rVIII-SingleChain at a dose to be determined by the investigator. Hemostatic efficacy will be assessed by the subject/caregiver and the investigator who will assess overall efficacy by a 4-point scale.

Trial Information
37 Sites
84 Participants
Recruiting
28 Days to 11 Years

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Study Site
Aurora,Colorado,United States,80045
Study Site
Chicago,Illinois,United States,60612
Study Site
Melbourne,Victoria,Australia,3052
Study Site
Linz,Austria,4020
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Vienna,Austria,1090
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Brest,France,29609
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Le Kremlin Bicetre,France,94270
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Lille Cedex,France,59037
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Nantes,France,44093
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Paris,France,75015
Study Site
Tbilisi,Georgia,0177
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Bonn,Germany,53127
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Bremen,Germany,28177
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Frankfurt/Main,Germany,60590
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Hannover,Germany,30159
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Milano,Italy,20122
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Beirut,Lebanon,11072240
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Kuala Lumpur,Malaysia,50400
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Amsterdam,Netherlands,1105AZ
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Njmegen,Netherlands,6525GA
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Utrecht,Netherlands,3584CX
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Cebu City,Philippines,6000
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Davao City,Philippines,8000
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Rzeszow,Poland,35-310
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Oporto,Portugal,4202-451
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Timisoara,Romania,300011
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Madrid,Spain,28046
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Lucerne,Switzerland,6000
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Bangkok,Thailand,10330
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Bangkok,Thailand,10700
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Chiang Mai,Thailand,50200
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Khon Kaen,Thailand,40002
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Songkla,Thailand,90110
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Adana,Turkey,01330
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Istanbul,Turkey,34098
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Izmir,Turkey,35100
Study Site
Lviv,Ukraine,79044

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov