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

Novo Nordisk

Status and phase: Terminated; Phase 1

Conditions: Healthy; Haemostasis

Treatments: Drug: eptacog alfa (activated); Drug: placebo; Drug: clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01561950

F7HAEM-1955

Details and patient eligibility

About

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®).

Enrollment: 91 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

91 participants in 2 patient groups, including a placebo group

Factor VII

Experimental group

Treatment:

Drug: clopidogrel

Drug: eptacog alfa (activated)

Placebo

Placebo Comparator group

Treatment:

Drug: clopidogrel

Drug: placebo