Congenital Bleeding Disorder Clinical Trial
Official title:
A Multi-Centre, Multinational, Open-Label, Single-Arm and Multiple Dosing Trial on Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency. Safety Extension Trial to F13CD-3760
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
n/a
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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