Bioequivalence of NovoSeven® and a NovoSeven® Formulation Stable at Room Temperature in Healthy Male Subjects

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: March 21, 2012
Last updated: May 11, 2016
Last verified: May 2016
This trial is conducted in Europe. The aim of this trial is to demonstrate bio-equivalence between the marketed activated recombinant human factor VII (NovoSeven®) (CP-rFVIIa) and a new formulation stable at 25°C (VII25).

Condition Intervention Phase
Acquired Bleeding Disorder
Acquired Haemophilia
Congenital Bleeding Disorder
Congenital FVII Deficiency
Glanzmann's Disease
Haemophilia A With Inhibitors
Haemophilia B With Inhibitors
Drug: activated recombinant human factor VII
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Single-centre, Randomised, Double-blind, Two-way Cross-over Trial Investigating the Bio-equivalence in Healthy Male Subjects of NovoSeven (CP-rFVIIa) and a Formulation of NovoSeven Stable at 25°C (VII25)

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Area under the plasma concentration versus time curve for FVIIa clot activity [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The maximum plasma concentration (Cmax) [ Designated as safety issue: No ]
  • Terminal half-life (t½) [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: April 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CP-rFVIIa Drug: activated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)
Experimental: VII25 Drug: activated recombinant human factor VII
One single dose administration, injected i.v. (into the vein)


Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Caucasian
  • Body Mass Index (BMI) between 18 and 27 kg/m^2, both inclusive
  • Good health as indicated by medical history, physical examination including vital signs and ECG, and clinical laboratory test results
  • Smoke less than 10 cigarettes (or equivalent) per day
  • Capable of giving written Informed Consent (IC)

Exclusion Criteria:

  • Evidence of clinically relevant pathology or potential thromboembolic risk based on medical and/or family history as judged by the Investigator
  • Known history of atherosclerosis, arteriosclerosis, thromboembolic events or known high levels of Troponin I
  • Known or suspected allergy to activated recombinant human factor VII or related products or any of the components of the formulation
  • Overt bleeding, including from gastrointestinal tract
  • Hepatitis (B or C) infection
  • HIV (human immunodeficiency virus) infection
  Contacts and Locations
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Please refer to this study by its identifier: NCT01561417

Paris, France, 75015
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT01561417     History of Changes
Other Study ID Numbers: NN1007-1744  2005-005379-14 
Study First Received: March 21, 2012
Last Updated: May 11, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hemophilia A
Hemophilia B
Hemorrhagic Disorders
Blood Platelet Disorders
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Pathologic Processes
Vascular Diseases processed this record on May 25, 2016