Clareo Health | A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)
A Study to Evaluate Efficacy of rFVIIIFc for Immune Tolerance Induction (ITI) in Severe Hemophilia A Participants With Inhibitors Undergoing the First ITI Treatment (verITI-8 Study)
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
Any age
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Ability of the participant or his legally authorized representative (e.g., parent or legal guardian) to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local participant privacy regulations
Male participants of any age diagnosed with severe hemophilia A (as confirmed from the medical record)
Currently diagnosed with high titer inhibitors (historical peak greater than or equal to (\>=) 5 Bethesda units per milliliter (BU/mL), according to medical records)
Previously treated with any plasma-derived or recombinant conventional or Extended Half-Life FVIII
You may not be if
Other coagulation disorder(s) in addition to hemophilia A
Previous immune tolerance induction (ITI)
History of hypersensitivity or anaphylaxis associated with any factor VIII (FVIII) administration
Planned major surgery scheduled during the study unless deferred until after study completion (minor surgery such as tooth extraction or insertion/replacement of central venous access device is allowed)
Abnormal renal function (serum creatinine \>1.5 milligram per deciliter (mg/dL) or 2 × upper limit of normal (ULN) for participant age based on local laboratory range) as assessed by local laboratory
Serum alanine aminotransferase or aspartate aminotransferase \> 5 × upper limit of normal (ULN) as assessed by local laboratory
