Efficacy of Activated Recombinant Human Factor VII in Healthy Volunteers Treated for Punch Biopsy Mediated Bleeding

Phase 1

Terminated

• Conditions: Haemostasis; Healthy
• Interventions: Drug: clopidogrel; Drug: eptacog alfa (activated); Drug: placebo

• Registration Number: NCT01561950
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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®).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Study First Submitted: 2012-03-21
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-23
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-22
• Last Update Posted: 2016-11-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 91

Inclusion Criteria

• PT/PTT within normal laboratory range (e.g., PT: 9.4-12.0)
• Platelet count within normal laboratory range

Exclusion Criteria

• The receipt of any investigational drug within 1 month prior to this trial
• Use of anticoagulation therapy-defined as vitamin K antagonists, platelet antagonists, heparin
• (or low molecular weight heparin), aspirin or NSAIDs (non-steroidal anti-inflammatory drug) within 30 days prior to trial
• African-American race
• Weight above or equal to 160 kg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	clopidogrel	-
Placebo	placebo	-
Factor VII	clopidogrel	-
Factor VII	eptacog alfa (activated)	-

Primary Outcome Measures

Name	Time	Method
Bleeding duration measured in minutes	From onset of bleeding till the end of the bleeding

Secondary Outcome Measures

Name	Time	Method
Blood volume reported in millilitres	From onset of bleeding till the end of the bleeding
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): R in minutes	Time to onset of clot formation
Clot dynamics on the TEG (thromboelastograph hemostasis analyzer): K in minutes	Time to achieve 20 mm clot strength
Adverse events, including thrombotic events	From screening to day 11-18
Change in coagulation-related parameters after pre-biopsy	From baseline to 15 minutes after pre-biopsy
Change in coagulation-related parameters after biopsy B2	From baseline to 3 hours after B2
Change in coagulation-related parameters after biopsy B3	From baseline to 1 hour after B3

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Neptune, New Jersey, United States