A Phase 1 interventional study of eptacog alfa (activated) and clopidogrel in Haemostasis and Healthy, sponsored by Novo Nordisk A/S. Terminated at 1 site in United States. Open to male participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2016-11-23.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in the United States of the America (USA). The aim of this trial is to evaluate the effectiveness of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with clopidogrel (Plavix®).
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: eptacog alfa (activated) · Drug: clopidogrel
Drug: clopidogrel · Drug: placebo
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
Also known as: activated recombinant human factor VII
Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).
If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
Bleeding duration measured in minutes
Time frame: From onset of bleeding till the end of the bleeding
Blood volume reported in millilitres
Time frame: From onset of bleeding till the end of the bleeding
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes
Time frame: Time to onset of clot formation
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes
Time frame: Time to achieve 20 mm clot strength
Adverse events, including thrombotic events
Time frame: From screening to day 11-18
Change in coagulation-related parameters after pre-biopsy
Time frame: From baseline to 15 minutes after pre-biopsy
Change in coagulation-related parameters after biopsy B2
Time frame: From baseline to 3 hours after B2
Change in coagulation-related parameters after biopsy B3
Time frame: From baseline to 1 hour after B3
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S