Treatment of Congenital Factor VII Deficiency
Treatment of Congenital Factor VII Deficiency
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.
Inclusion Criteria:

 -  Signed informed consent by the patient or next of kin or legally acceptable
 representative to collect data on treatment of a given bleeding episode, surgical
 event or prophylactic regimen as specified in the protocol. If informed consent is
 provided by the next of kin or legally acceptable representative, consent must also be
 obtained from the patient as soon as he/she is able to do so. Informed consent should
 preferentially be obtained before initiation of treatment or as a minimum before entry
 of data into the database

 -  Any patient with a FVII deficiency for whom treatment of bleeding episodes, prevention
 related to surgery and primary/secondary prophylaxis is considered necessary by the
 treating physician can be enrolled

 -  Patients with FVII deficiency without any immediate need for treatment will be entered
 as stand by registered patients with capture of baseline- and demographic data only.
 Admission data is entered once an event occurs