A Phase 4 interventional study of activated recombinant human factor VII and activated recombinant human factor VII in Congenital Bleeding Disorder, Haemophilia A With Inhibitors and Haemophilia B With Inhibitors, sponsored by Novo Nordisk A/S. Completed at 14 sites in United States. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2023-12-29.
Sponsored by Novo Nordisk A/S · Phase 4, Interventional, and Treatment
This trial is conducted in North America. The aim of this trial is to compare the safety and efficacy of activated recombinant human factor VII in patients with haemophilia A or B undergoing major surgical procedures.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 36 is below the median of 51 across 253 interventional 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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Exclusion Criteria:
Drug: activated recombinant human factor VII
Drug: activated recombinant human factor VII
Other: factor IX · Drug: factor VIII
Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
Presence and maintenance of haemostasis
Changes in FVII:C (Factor VII clotting activity) levels following administration of activated recombinant human factor VII
Adverse Events
Changes in coagulation-related parameters
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S