An observational study in Congenital Bleeding Disorder and Glanzmann's Disease, sponsored by Novo Nordisk A/S. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by Novo Nordisk A/S · Observational
This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 4 is below the median of 100 across 229 observational studies indexed under Hemostatic Disorders.
Browse Hemostatic Disorders studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with GT, who are enrolled in this study and to whom activated recombinant human factor VII (NovoSeven®) is administered in the study period, shall be included.
Exclusion Criteria:
Drug: eptacog alfa (activated)
Patients will be treated according to routine clinical practice at the direction of the treating physician. Data will be collected once a year after patient is registered with baseline visit until end of the study.
Also known as: activated recombinant factor VII, NovoSeven®
Therapy-related thrombosis
Time frame: From onset of treatment until 6 hours after treatment onset
Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate
Time frame: Within 30 days of end of treatment for bleeding episodes
Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate
Time frame: Within 24 hours after surgery for surgery/delivery
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S