Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pfizer
Age
0–15
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male subjects, aged less than 6 years, with moderately severe to severe hemophilia A.
A negative FVIII inhibitor titer at screening, and a medical history negative for a past FVIII inhibitor.
At least 20 exposure days to any FVIII replacement product.
Adequate hepatic and renal function
CD4 count \> 400 cells/uL, and if receiving antiviral therapy must be on a stable regimen
Additional criteria for subjects participating in the PK assessment:
Male subjects as described immediately above except they must have a FVIII Activity of less than or equal to 1% confirmed by the central laboratory screening test
Age \< 6 years at time of PK assessment.
The subject's size is sufficient to permit PK-related phlebotomy.
The subject is able to comply with the procedures conducted during the PK assessment, including a mandatory 72-hour washout period preceding the PK assessment.
You may not be if
A history of FVIII inhibitor.
Presence of a bleeding disorder in addition to hemophilia A.
Treatment with any investigational drug or device within 30 days before the time of signing the informed consent form.
Major or orthopedic surgery planned to occur during the course of the study.
Regular (e.g., daily, every other day) use of antifibrinolytic agents or medications known to influence platelet function such as aspirin or certain nonsteroidal anti-inflammatory drugs (NSAIDs), or regular, concomitant therapy with immunomodulating drugs (e.g., intravenous immunoglobulin \[IVIG\], routine systemic corticosteroids).
Known hypersensitivity to hamster protein.
Clareo Health | Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII
