1 Study Matches
Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with hemophilia A with or without FVIII inhibitors
This is a drug study that will examine the safety and effectiveness of once-weekly and once-monthly Mim8 treatment in children (age 1-11 years) with hemophilia A with or without factor VIII (FVIII) inhibitors.
The study will last for about 54-98 weeks depending on how long a child will be followed before they start receiving Mim8. Once the treatment starts, the child will receive the medicine once a week for the first 26 weeks. There will be 12-17 clinical visits. Blood will be drawn at 13 of the visits.
$75 per visit to cover travel expenses
Bree Kelly - at firstname.lastname@example.org or 717-531-0003, ext=281498
Younger than 18 years old
Inclusion Criteria:Congenital haemophilia A of any severity based on medical records
Pt in need of treatment with factor VIII or bypassing agent in the 26 weeks prior to screening
Age 1-11 years
Patients with endogenous FVIII activity >/= 1% must have at least 1 treated bleed within 6 months of screening
For patients previously untreated with FVIII must have severe haemophilia A (FVIII activity < 1%)
Exclusion Criteria:Previous or current treatment for thromboembolic disease or signs of thromboembolic disease
Immune tolerance induction planned after treatment initiation
Exposure to non-factor haemostatic productsfor bleeding prophylaxix within 6 months prior to first dose
Pts with body weight below 3 kg at screening