51 previously treated patients 1
ABR for total bleeds
Primary endpoint : ABR measured within 48 hours 1
Secondary endpoint : ABR during the 6-month study 1 , 3
0
(
Median ABR
n = 51 ) ( IQR = 0.0 ; 4.0 )
2
Median ABR
( n = 51 ) ( IQR = 0.0 ; 6.0 )
2x / week prophylaxis
2
Median ABR
( n = 21 )* ( range : 0-14.1 )
3x / week or EOD prophylaxis
2Median ABR
( n = 30 )* ( range : 0-18.1 )
* During the LEOPOLD Kids study , one patient was moved from a 2x / week prophylaxis regimen to a 3x / week prophylaxis regimen .
†
In an ongoing extension study , a 13-year-old PTP had a titer of 0.6 BU after 550 EDs concurrent with an acute infection and positive lgG anticardiolipin antibodies . His ABR was zero and no change in therapy was required . 1
SELECTED IMPORTANT SAFETY INFORMATION
Catheter-related infections may occur when KOVALTRY ® is administered via central venous access devices ( CVADs ). These infections have not been associated with the product itself .
The most frequently reported adverse reactions in clinical trials ( ≥3 %) were headache , pyrexia , and pruritus .
89.7 % of bleeding episodes resolved with ≤2 infusions of KOVALTRY ® 1
inhibitors
in the completed study of
51 previously treated patients 1
People with hemophilia A may develop inhibitors to rFVIII . People with a history of inhibitors and previously untreated children were excluded from LEOPOLD Kids — Part A 1 .