Conditions: Congenital Bleeding Disorder Congenital FXIII Deficiency
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 63
Healthy volunteers: no

Brief summary:
This trial is conducted in Asia, Europe and North America. The aim of the trial is to investigate the safety of monthly replacement therapy of recombinant factor XIII in patients with congenital FXIII deficiency. The trial continues until the product is commercially available, but an interim assessment will take place when all subjects have completed 52 weeks in the trial.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: catridecacog
Intervention descriptions: intervention 1: Monthly administration of recombinant factor XIII as preventative treatment of bleeding episodes. Dose: 35 IU/kg body weight intravenous (into the vein)

Protocol document: