Clareo Health | Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Baxalta now part of Shire
Age
0–6
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject is less than 6 years of age
Severe or moderately-severe hemophilia A as defined by a baseline factor VIII level \<= 2%, documented at screening or on the basis of historical data (e.g., at hemophilia diagnosis)
Documented medical history of at least 50 exposure days for treatment with all other factor VIII products
Subject's parent or legally authorized representative has provided informed consent
You may not be if
Detectable inhibitor to factor VIII measured in the screening sample by the local or central hemostasis laboratory
History of inhibitor to factor VIII at any time prior to screening
Subject has any one of the following laboratory abnormalities at the time of screening:
1. platelet count \< 100,000/mm3
2. hemoglobin concentration \< 10 g/dL (100 g/L)
3. serum creatinine \> 1.5 times the ULN for age
4. total bilirubin \> 2 times the ULN for age
Subject has an inherited or acquired hemostatic defect other than hemophilia A (e.g., platelet dysfunction secondary to uremia, liver failure, von Willebrand's Disease)
Subject has known hypersensitivity to RECOMBINATE rAHF
Subject is currently participating in another investigational drug study or has participated in any clinical study involving an investigational drug within 30 days of study entry
Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
