A Phase 1 interventional study of warfarin and eptacog alfa (activated) in Haemostasis and Healthy, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to male participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-25.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII to mitigate experimentally-induced bleeding in healthy volunteers treated with warfarin to reach a targeted INR (International Normalization Ratio).
Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 101 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: warfarin
Drug: eptacog alfa (activated) · Drug: placebo
After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed
If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration
Also known as: activated recombinant human factor VII
If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration
Bleeding duration measured in minutes after biopsies in trial part A
Time frame: From onset of bleeding till the end of the bleeding
Bleeding duration measured in minutes after biopsy B1 in trial part B
Time frame: From onset of bleeding till the end of the bleeding
Blood volume reported in millilitres after biopsies in trial part A
Time frame: From onset of bleeding till the end of the bleeding
Blood volume reported in millilitres after biopsy B1 in trial part B
Time frame: From onset of bleeding till the end of the bleeding
Adverse events, including thrombotic events
Time frame: From day 0 to days 14-28
Change in coagulation-related parameters after biopsy B1
Time frame: From baseline to 3 hours after B1
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 3 hours after B3
Clot dynamics: R in minutes (trial part B)
Time frame: Time to onset of clot formation
Clot dynamics: K in minutes (trial part B)
Time frame: Time to achieve 20mm clot strength
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Novo Nordisk A/S