Overview

Safety and Efficacy of Monthly Replacement Therapy With Recombinant Factor XIII (rFXIII) in Paediatric Subjects With Congenital Factor XIII A-subunit Deficiency

Status:
Completed
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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 (mentorâ„¢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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Criteria
Inclusion Criteria:

- Completed participation in trial F13CD-3760 (NCT01230021)

Exclusion Criteria:

- Known or suspected hypersensitivity to trial product or related products

- Known history of development of inhibitors against FXIII (factor XIII)

- Hereditary or acquired coagulation disorder other than FXIII congenital deficiency

- Platelet count (thrombocytes) less than 50X10e9 / L

- Previous history of autoimmune disorder involving autoantibodies e.g., systemic lupus
erythematosus

- Previous history of arterial or venous thromboembolic events e.g., cerebrovascular
accident or deep vein thrombosis

- Any disease or condition which, judged by the trial physician, could imply a potential
hazard to the subject, interfere with the trial participation or trial outcome
including renal and/or liver dysfunction