Conditions: Congenital Bleeding Disorder Congenital FXIII Deficiency
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 6
Healthy volunteers: no

Brief summary:
This trial is conducted in Europe and United States of America (USA). The aim of this clinical trial is to investigate the pharmacokinetics (at which rate the substance is distributed and eliminated from the body) and the safety profile of catridecacog (recombinant factor XIII (rFXIII)) in children with congenital FXIII A-subunit deficiency. Young children (1 to less than 6 years old) with congenital FXIII deficiency are evaluated.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: catridecacog
Intervention descriptions: intervention 1: Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg bodyweight

Protocol document: