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
Diagnosis of congenital FXIII A-subunit deficiency (confirmed by genotyping at screening visit)
Treatment with regular FXIII replacement therapy initiated at least 6 months prior to screening and one of the following : a documented history of at least one 1 treatment-requiring bleeding episode prior to initiation of regular replacement therapy or a documented family history of FXIII congenital deficiency (only for subjects on regular replacement therapy prior to screening)
Documented history of at least two 2 bleeding episodes requiring treatment with FXIII containing blood products within the last 12 months prior to screening (only for subjects receiving on-demand treatment prior to screening)
You may not be if
Known neutralizing antibodies (inhibitors) towards FXIII
Any known congenital or acquired coagulation disorder other than congenital FXIII deficiency
Documented history of at least 2 treatment-requiring bleeding episodes per year during previous regular replacement therapy with FXIII containing blood products (fresh frozen plasma (FFP), plasma-derived FXIII (pd FXIII) and cryoprecipitate)
Known or suspected allergy to trial product(s) or related products
Planned major surgery during the trial period. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject
Renal insufficiency defined as current dialysis therapy
Any history of confirmed venous or arterial thrombo-embolic events
Clareo Health | Evaluation of Recombinant Factor XIII for Prevention of Bleeding in Patients With FXIII Inherited Deficiency
