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

Brief summary:
This trial will be conducted in Asia, Europe and the United States of America (USA).

The aim of this clinical trial is to investigate long-term safety of rFXIII when administered for prevention of bleeding episodes in children aged between 1 and 6 years with congenital FXIII A-subunit deficiency. This trial is an extension to trial F13CD-3760 (mentor™4, NCT01230021). If applicable the trial will be extended up to maximum 3 years dependent on when recombinant factor XIII will be commercially available in subject's respective country for use in children of 1-6 years of age.

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 body weight every 4th week

Protocol document: