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Hemophilia A

An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
NCT02172950 | PHASE 3 | INTERVENTIONAL

This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs) with severe congenital hemophilia A and previous exposure to FVIII products who achieve at least 100 exposure days (EDs) to rVIII-SingleChain in this study, as well as in previously untreated patients (PUPs) with no previous exposure to any FVIII product who achieve at least 50 EDs to rVIII-SingleChain in this study. A substudy (open to both PTPs and PUPs) will investigate the use of rVIII-SingleChain in surgery. A substudy (open to PUPs who develop an inhibitor to rVIII-SingleChain) will investigate the use of rVIII-SingleChain in immune tolerance induction (ITI) therapy.

Trial Information
64 Sites
246 Participants
Recruiting
18 Years to 60 Years

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Study Site
San Diego,California,United States,92103
Study Site
Aurora,Colorado,United States,80045
Study Site
Hartford,Connecticut,United States,06106
Study Site
Miami,Florida,United States,33136
Study Site
Chicago,Illinois,United States,60612
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New Orleans,Louisiana,United States,70112
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Dallas,Texas,United States,75390
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Houston,Texas,United States,77030
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Milwaukee,Wisconsin,United States,53226
Study Site
Melbourne,Australia,3052
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Nedlands,Australia,WA6009
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Perth,Australia,WA6000
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Graz,Austria,8036
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Linz,Austria,4020
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Wien,Austria,1090
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Wien,Austria,1090
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Saint John,Canada,E2L4L2
Study Site
Hradec Kralove,Czechia,50005
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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
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Tbilisi,Georgia,0179
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Bonn,Germany,53127
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Frankfurt,Germany,60596
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Giessen,Germany,35385
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Hannover,Germany,30625
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Debrecen,Hungary,4032
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Dublin,Ireland,12
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Milano,Italy,20122
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Hyogo,Japan,663-8501
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Nagoya,Japan,466-8550
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Okayama,Japan,710-8602
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Saitama,Japan,339-8551
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Tokyo,Japan,160-0023
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Beirut,Lebanon,165191
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Kuala Lumpur,Malaysia,50400
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Amsterdam Zuidoost,Netherlands,1105AZ
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Nijmegen,Netherlands,6500
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Utrecht,Netherlands,3584
Study Site
Cebu City,Philippines,6000
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Davao City,Philippines,8000
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Gdansk,Poland,80-952
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Krakow,Poland,31-531
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Rzeszow,Poland,35-301
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Wroclaw,Poland,50-367
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Porto,Portugal,4200-319
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Bucharest,Romania,011026
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Timisoara,Romania,300011
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Parktown,South Africa,2193
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A Coruna,Spain,15006
Study Site
Barcelona,Spain,08035
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Madrid,Spain,28046
Study Site
Valencia,Spain,46026
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Luzern,Switzerland,6000
Study Site
Bangkok,Thailand,10330
Study Site
Bangkok,Thailand,10700
Study Site
Chiang Mai,Thailand,50200
Study Site
Khon Kaen,Thailand,40002
Study Site
Songkhla,Thailand,90110
Study Site
Dnipropetrovsk,Ukraine,49102
Study Site
Lviv,Ukraine,79044
Study Site
London,United Kingdom,NW32QG

Study Eligibility Criteria

Additional Studies

Additional studies can be found at ClinicalTrials.gov