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
7–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level \<= 2% of normal, as tested at screening
The subject has a documented history of at least 150 exposure days to factor VIII concentrates (either plasma-derived or recombinant)
The subject is within 7 to 65 years of age
The subject has a Karnofsky performance score \> (greater than) 60
The subject is human immunodeficiency virus negative (HIV-) or is HIV+ with a CD4 count \>= 400 cells/mm³ (CD4 count determined at screening, if necessary)
The subject has been on a documented on-demand treatment regimen for at least 12 months immediately prior to enrollment
The subject has a documented history (e.g. in medical charts or dispensing information, or signed investigator statement) of at least 8 joint hemorrhages in the 12 months immediately prior to enrollment
The subject resides within the coverage area of the mobile compliance device; coverage area will be determined at screening
The subject or the subject's legally authorized representative has provided written informed consent
You may not be if
The subject has a known hypersensitivity to factor VIII concentrates or mouse or hamster proteins
The subject has a history of factor VIII inhibitors with a titer \>= 0.6 BU (by Bethesda or Nijmegen assay) at any time prior to screening
The subject has a detectable factor VIII inhibitor at screening, with a titer \>= 0.4 BU (by Nijmegen Assay) in the central laboratory
The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) \> 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g., qualitative platelet defect or von Willebrand's Disease)
The subject has been treated during the last sixty (60) days prior to or is being treated at screening/enrollment with an immunomodulating drug.
The subject has participated in another investigational study within thirty (30) days of enrollment
The subject has previously participated in a clinical study with rAHF-PFM
The subject's clinical condition may require a major surgery (defined as moderate to critical risk and perioperative blood loss ≥ 500 mL) during the period of the subject's participation in the study
The subject is female of childbearing potential with a positive pregnancy test
Clareo Health | Prophylaxis Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
