An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bioverativ, a Sanofi company
With
Swedish Orphan Biovitrum
Age
0–5
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Ability of the participant's legally authorized representative (e.g. their parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local participant privacy regulations.
Weight \>=3.5 kg at the time of screening.
Severe hemophilia A defined as less than (\<) 1 IU/dL (\<1%) endogenous FVIII documented in the medical record or as tested during the Screening Period.
You may not be if
Any exposure to blood components, factor VIII replacement products, including commercially available rFVIIIFc at any time prior to or during screening.
History of positive inhibitor testing. A prior history of inhibitors was defined based on a patient's historical positive inhibitor test using the local laboratory Bethesda value for a positive inhibitor test (ie, equal to or above lower level of detection).
History of hypersensitivity reactions associated with any rFVIIIFc administration.
Other coagulation disorder(s) in addition to hemophilia A.
Any concurrent clinically significant major disease that, in the opinion of the Investigator, would make the participant unsuitable for enrollment.
Current systemic treatment with chemotherapy and/or other immunosuppressant drugs.
Clareo Health | An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
