None listed
Conditions
Interventions
Subjects who will practice on-demand therapy during segment 1 will switch to protocoldefined prophylactic regimen B to be followed during segment 2. Alternatively, all other
subjects, who will prac
Sponsors
Pfizer Inc.,
Eligibility
Sex/Gender
Male
Age
1 Years to 6 Years
Inclusion criteria
Inclusion criteria: Males 400/μL. 11.Prothrombin time (PT) ≤1.25 × ULN, or international normalized ratio (INR) ≤1.5. 12. The subject is not receiving treatment for HIV or hepatitis infection, or the subject is on a stable antiviral regimen at the time of signing the consent/assent form.13 The subject is able to comply with the mandatory 72-hour FVIII washout preceding each FVIII:C and FVIII inhibitor assessment during the study. For more details please see the section Inclusion Criterias into the protocol.
Exclusion criteria
Exclusion criteria: 1. A history of FVIII inhibitor (clinical or laboratory-based assessment). For laboratory assessments, any measured Bethesda inhibitor titer ≥0.6 BU/mL, regardless of the laboratory normal range, or any measured Bethesda inhibitor titer greater than the ULN for the laboratory performing the assay. 2.Presence of a bleeding disorder in addition to hemophilia A. 3.Treatment with any investigational drug or device within 30 days before the time of signing the consent/assent form. 4.Major or orthopedic surgery planned to occur within the period following the signing of the consent/assent form to the Final Study Contact (ie, during the course of the study). 5.Regular (eg, daily, every other day) use of antifibrinolytic agents or medications known to influence platelet function such as aspirin or certain nonsteroidal antiinflammatory drugs (NSAIDs). 6. Regular, concomitant therapy with immunomodulating drugs (eg, intravenous immunoglobulin [IVIG], routine systemic corticosteroids). 7. Known hypersensitivity to hamster protein. 8. Any condition(s) that compromises the subject’s ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; inability to properly store study drug; expectation of poor compliance in study related documentation). 9.Unwilling or unable to follow the terms of the protocol. For more details please see the section Inclusion Criterias into the protocol.
Countries
Croatia, Jordan, Mexico, Oman, Romania, Turkey, United States
Outcome results
None listed