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
Study duration per participants was approximately 60 weeks (maximum 8 weeks for screening and 52 weeks of treatment).
All participants completing or remaining at the end of study were offered participation in the planned extension trial.
Age
0–11
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Participant must be younger than 12 years of age, at the time of signing the informed consent.
Severe hemophilia A defined as \<1 international units per deciliter (IU/dL) (\<1 percent \[%\]) endogenous Factor VIII (FVIII) as documented either by central laboratory testing at Screening or in historical medical records from a clinical laboratory demonstrating \<1% FVIII coagulant activity (FVIII:C) or a documented genotype known to produce severe hemophilia A.
Previous treatment for hemophilia A (prophylaxis or on-demand) with any recombinant and/or plasma-derived FVIII, or cryoprecipitate for at least 150 exposure days (EDs) for participants aged 6 to \<12 years and above 50 EDs for participants aged \<6 years.
Weight above or equal to 10 kg.
You may not be if
History of hypersensitivity or anaphylaxis associated with any FVIII product.
History of a positive inhibitor (to FVIII) test defined as greater than or equal to (\>=) 0.6 Bethesda units (BU/mL), or any value greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL, or clinical signs or symptoms of decreased response to FVIII administrations. Family history of inhibitors would not exclude the participant.
Positive inhibitor test result, defined as \>=0.6 BU/mL at Screening.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Clareo Health | Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
