Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
New York Presbyterian Hospital
With
Manchester University NHS Foundation Trust
Subjects will be randomized into a low-dose or high-dose immune tolerance regimen and this study will compare the success rates, the time to achieve tolerance,the complications and the cost of both regimens.It will also aim to identify predictors of successful immune tolerance.
Age
0–7
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Severe hemophilia A (FVIII level \<1%).
A maximum historical inhibitor titer of between 5 BU and 200 BU that must be confirmed once prior to the beginning of ITI.
The inhibitor titer should be \<10 BU at the start of ITI, confirmed once.
The inhibitor must be present for \<24 months when ITI begins.
Maximum age of 7 at the start of ITI.
Willingness to comply with the protocol.
You may not be if
Moderate or mild hemophilia A (FVIII level \>1%).
Spontaneous disappearance of the inhibitor prior to ITI.
Historical maximum inhibitor titer \<5 BU or \> 200 BU before starting ITI.
Inhibitor titer \> 10 BU at the start of ITI.
Inhibitor present for more than 24 months before starting ITI.
Systemic immunomodulatory drug therapy during immune tolerance e.g. corticosteroids (\< 5 days every 2 months maximum dose 2 mg/kg or 60 mg/day), azathioprine, cyclophosphamide, high-dose immunoglobulin or the use of a protein A column or plasmapheresis.
Age \> 7 years at the start of ITI.
Inability or unwillingness to comply with the protocol.
