A Phase 2 interventional study of activated recombinant human factor VII and placebo in Acquired Bleeding Disorder and Dengue Haemorrhagic Fever, sponsored by Novo Nordisk A/S. Completed at 9 sites in 3 countries. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-01-11.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).
279 studies on the registry are indexed under Dengue; 45 are open to participants now.
This study's enrollment of 28 is below the median of 123 across 195 interventional studies indexed under Dengue.
Browse Dengue 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: placebo
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration
Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration
Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration
Coagulation related variables
Adverse events
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