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

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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