Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
6–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
For subjects who participated in F13CD-1725:
Previous participation (means up to and inclusive Visit 16, (End of Trial)) in F13CD-1725
For all other subjects:
Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit or documented results from previously performed genotyping)
Body weight at least 20 kg
You may not be if
Known neutralizing antibodies (inhibitors) towards FXIII
Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
Platelet count (thrombocytes) of less than 50 × 109/L. For subjects who participated in F13CD-1725 platelet count from visit 15 in F13CD-1725 must be used for evaluation.
Females of childbearing potential who are pregnant, breastfeeding or are not using adequate contraceptive methods
Clareo Health | Safety of Monthly Recombinant Factor XIII Replacement Therapy in Subjects With Congenital Factor XIII Deficiency: An Extension to Trial F13CD-1725
