Conditions: Congenital Bleeding Disorder Haemophilia B
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 74
Healthy volunteers: no

Brief summary:
This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

Detailed description:

Arms:
arm 1: None arm 2: None arm 3: None

Interventions: intervention 1: nonacog beta pegol intervention 2: nonacog beta pegol intervention 3: nonacog beta pegol
Intervention descriptions: intervention 1: One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience intervention 2: One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience intervention 3: Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode

Protocol document: