Phase 3, prospective, multi-center, open label study to investigate safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII (BAX 855) in previously untreated patients (PUPs) < 6 years with severe hemophilia A (FVIII < 1%)

Clinical Trial Details

The purpose of this study is to investigate safety, immunogenicity and hemostatic efficacy of PEGylated recombinant FVIII (BAX 855) in previously untreated patients (PUPs) younger than 6 years of age with severe hemophilia A (baseline FVIII level < 1%) and < 3 exposure days to ADVATE, BAX 855 or plasma transfusion.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Ilene Goldberg
(212) 746-3403
igoldber@med.cornell.edu

Primary Investigator(s)

Catherine McGuinn, MD (UES)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1508016500

Status

Open to Enrollment

Age Group

Pediatric

Disease

Hemophilia A