Clinical trial NCT03528551
Conditions: Congenital Bleeding Disorder Haemophilia A
Sponsor: Novo Nordisk A/S
Start date: 2018-04-30; Completion date: 2020-12-03
Enrollment: 160 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will look at how a known study medicine N8-GP works in previously N8-GP treated people with haemophilia A. The aim is to look at how N8-GP works during regular use. Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A for several years. Participants will get an injection of N8-GP into a blood vessel, one, two or three times weekly. Participants will get more doses if they bleed or if they will need a surgery. The study will last for about 2 years. Participants will have at least 9 visits with the study doctor. If participants agree to be in this study, they will get their first injection (in this study) at the first visit. Participants will also get an injection at visit 3, 5 and 7. Participants will be trained to give all other injections themselves. Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood thinners) during the study.

Detailed description:

Arms: arm 1: All participants will receive turoctocog alfa pegol (N8-GP) once weekly. arm 2: All participants will receive N8-GP twice weekly. arm 3: All participants will receive N8-GP three times weekly.
Interventions: intervention 1: Turoctocog alfa pegol intervention 2: Turoctocog alfa pegol intervention 3: Turoctocog alfa pegol
Intervention descriptions: intervention 1: Turoctocog alfa pegol 75 IU/kg body weight will be administered once weekly as intravenous injections for a duration of 2 years. intervention 2: Turoctocog alfa pegol 60 IU/kg body weight (for patients younger than 12 years) and 50 IU/kg body weight (for patients, 12 years or older) will be administered twice weekly as intravenous injections for a duration of 2 years. intervention 3: Turoctocog alfa pegol 50 IU/kg body weight will be administered three times weekly as intravenous injections for a duration of 2 years.

Protocol documents:
Prot_000.pdf: 
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