Conditions: Congenital Bleeding Disorder Congenital FXIII Deficiency
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 41
Healthy volunteers: no

Brief summary:
The trial is conducted in Europe, North America and Asia. The aim of this trial is to evaluate catridecacog (recombinant factor XIII (rFXIII)) treatment in patients with inherited FXIII deficiency. It is expected that recombinant FXIII can be used for the prevention of bleeding episodes.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: catridecacog
Intervention descriptions: intervention 1: 35 IU/kg body weight, i.v. administration, once every 4 weeks

Protocol document: