- * Diagnosis of severe hemophilia A defined as \<1% FVIII:C documented in medical records.
- * Males between 18 and 65 years of age (Parts 1 and 2).
- * Males between 12 and 65 years of age (Part 3).
- * Subjects who have received or are currently receiving FVIII products (plasma-derived and/or recombinant FVIII) and have had \>150 exposure days (EDs) with a FVIII product
- * Written informed consent for study participation obtained before undergoing any study specific procedures.
Hemophilia A
An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
NCT01486927 | PHASE 2 | INTERVENTIONAL
This is an open-label, non-randomized, efficacy, safety and pharmacokinetic (PK) study comparing octocog alfa and rVIII-SingleChain. The study consists of three parts, a PK period (Part 1), a continuation of dosing safety and efficacy period (Part 2) and a safety, efficacy, and repeat PK period (Part 3) and also includes a surgical sub-study for subjects enrolled in Parts 2 and 3.
Trial Information
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Study Site
Sacramento,California,United States,95817
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
Study Site
New Orleans,Louisiana,United States,70112
Study Site
Houston,Texas,United States,77030
Study Site
Milwaukee,Wisconsin,United States,53226
Study Site
Nedlands,Australia,WA6009
Study Site
Perth,Australia,WA6000
Study Site
Graz,Austria,8036
Study Site
Vienna,Austria,1090
Study Site
New Brunswick,Canada,E2L4L2
Study Site
Hradec Králové,Czech Republic,50005
Study Site
Berlin,Germany,10249
Study Site
Berlin,Germany,13353
Study Site
Bonn,Germany,53127
Study Site
Gießen,Germany,35392
Study Site
Hamburg,Germany,20095
Study Site
Hannover,Germany,30159
Study Site
Heidelberg,Germany,69123
Study Site
Debrecen,Hungary,H-4032
Study Site
Florence,Italy,50134
Study Site
Milan,Italy,20122
Study Site
Padova,Italy,35123
Study Site
Padova,Italy,35128
Study Site
Torino,Italy,10126
Study Site
Kashihara, Nara,Japan
Study Site
Kitakyushu, Fukuoka,Japan
Study Site
Nagoya,Japan,466-85660
Study Site
Nishinomiya, Hyogo,Japan
Study Site
Okayama,Japan,710-8602
Study Site
Saitama,Japan
Study Site
Suginami-ku, Tokyo,Japan
Study Site
Tokyo,Japan,160-0023
Study Site
Beirut,Lebanon
Study Site
Kuala Lumpur,Malaysia,50400
Study Site
Utrecht,Netherlands,3584CX
Study Site
Cebu City,Philippines,6000
Study Site
Davao City,Philippines,8000
Study Site
Wroclaw,Silesia,Poland,50-367
Study Site
Gdansk,Poland,80-952
Study Site
Krakow,Poland,31-501
Study Site
Bucharest,Romania,011026
Study Site
Barnaul,Russian Federation,656038
Study Site
Kemerovo,Russian Federation,650066
Study Site
Cape Town,South Africa,7295
Study Site
Johannesburg,South Africa,2193
Study Site
Barcelona,Spain
Study Site
La Coruna,Spain
Study Site
Valencia,Spain,46026
Study Site
Dnipropetrovsk,Ukraine,49102
Study Site
Donetsk,Ukraine,830045
Study Site
Lviv,Ukraine,79044
Study Site
London,United Kingdom,NW32QG
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov