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Trial record 7 of 7 for:    "Thrombasthenia"

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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01561417
First received: March 21, 2012
Last updated: June 28, 2012
Last verified: June 2012
  Purpose

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
Healthy
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)

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561417

Locations
France
Paris, France, 75015
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Birgitte Scharling Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01561417     History of Changes
Other Study ID Numbers: NN1007-1744, 2005-005379-14
Study First Received: March 21, 2012
Last Updated: June 28, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Thrombasthenia
Blood Coagulation Disorders
Disease
Hemophilia A
Hemophilia B
Hemorrhage
Hemorrhagic Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Blood Platelet Disorders
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014