A Phase 2 interventional study of activated recombinant human factor VII and activated recombinant human factor VII in Acquired Bleeding Disorder and Bleeding During/Following Surgery, sponsored by Novo Nordisk A/S. Completed at 18 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-13.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.
503 studies on the registry are indexed under Hemostatic Disorders; 71 are open to participants now.
This study's enrollment of 208 is above 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.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: activated recombinant human factor VII
Drug: activated recombinant human factor VII
Drug: placebo
120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure
60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure
Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure
Total number of RBC units transfused during the perioperative period
Number of RBC units transfused by surgical phase
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