Congenital Bleeding Disorder Clinical Trial
Official title:
Treatment of Congenital Factor VII Deficiency. A Prospective Observational Study
This study is conducted globally. The aim of this study is to describe the treatment
modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with
factor VII (FVII) deficiency in addition to evaluate the presence (in already treated
patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related
thrombosis.
Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use
(CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII
(rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation
Registry (STER, NCT01269138). These patients can also have been treated with other
haemostatics for systemic administration.
n/a
Observational Model: Cohort, Time Perspective: Prospective
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|---|---|---|---|
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N/A |