Treatment of Congenital Factor VII Deficiency
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/13/2017 |
| Start Date: | October 2005 |
| End Date: | January 2012 |
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.
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
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