An observational study in Congenital Bleeding Disorder, Congenital FVII Deficiency and Glanzmann's Disease, sponsored by Novo Nordisk A/S. Completed at 1 site in Germany. Per ClinicalTrials.gov, last updated 2016-12-07.
Sponsored by Novo Nordisk A/S · Observational
This NON INTERVENTIONAL OBSERVATIONAL STUDY is conducted in Europe. The primary aim is to observe the haemostatic efficacy of NovoSeven® treatment during routine practice in German clinics. The observational study observes patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven® for treatment of a bleeding episode or for the prevention of a bleeding when undergoing surgery or an invasive procedure.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 64 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.
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Patients with congenital haemophilia with inhibitors to coagulation factors VIII or IX, acquired haemophilia, congenital FVII deficiency, or Glanzmann's thrombasthenia who have received at least one dose of NovoSeven®.
Exclusion Criteria:
Drug: eptacog alfa (activated)
A NON INTERVENTIONAL OBSERVATIONAL STUDY: Doses and frequency of injections to be prescribed by the physician as a result of the normal clinical evaluation
Also known as: NovoSeven®, F7, activated recombinant human factor VII
Proportion of acute bleeding episodes for which haemostasis (defined as stop or significant reduction of bleeding) will be achieved
Time frame: within 9 hours after initiation of treatment with NovoSeven® or of invasive procedures for which haemostasis will be maintained during the time period of haemostatic coverage with NovoSeven®
Time proportion of acute bleeding treatments resulting in effective pain relief
Time frame: within 9 hours after initiation of treatment with NovoSeven®
Proportion of patients experiencing one or more re-bleeds
Time frame: within 24 hours after begin of an acute bleeding episode that was successfully treated with NovoSeven® (stop or significant reduction of bleeding)
This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S