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Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State

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ClinicalTrials.gov Identifier: NCT01562587
Recruitment Status : Completed
First Posted : March 26, 2012
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Haemophilia B Drug: activated recombinant human factor VII Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State
Study Start Date : September 2002
Actual Primary Completion Date : May 2003
Actual Study Completion Date : May 2003

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Adults Drug: activated recombinant human factor VII
A single bolus dose is administered. Injected intravenously
Experimental: Paediatric Drug: activated recombinant human factor VII
A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Area under the concentration curve from 0-12 hours

Secondary Outcome Measures :
  1. CL, the total body clearance
  2. Cmax, the maximum concentration
  3. tmax, the time to maximum concentration
  4. t1/2, the terminal half-life
  5. Area under the concentration curve from time 0-infinity
  6. Vss, the apparent volume of distribution at steady state
  7. Adverse events

Eligibility Criteria
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Ages Eligible for Study:   3 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
  • Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors

Exclusion Criteria:

  • Known hypersensitivity to activated recombinant human factor VII or any of its components
  • Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
  • Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
  • Clinical manifestation of active/recent bleeding
  • Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
  • Body Mass Index (BMI) outside normal range
  • Known abuse of elicit drugs and/or alcohol
  • Renal insufficiency
  • Hepatic disease
  • Cardiovascular disease
  • Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01562587


Locations
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Germany
Novo Nordisk Investigational Site
Bremen, Germany, 28205
Novo Nordisk Investigational Site
Frankfurt, Germany, 60590
Greece
Novo Nordisk Investigational Site
Athens, Greece, GR-11527
Italy
Novo Nordisk Investigational Site
Firenze, Italy, 50134
Novo Nordisk Investigational Site
Milano, Italy, 20124
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
United Kingdom
Novo Nordisk Investigational Site
London, United Kingdom, WC1N 3JH
Novo Nordisk Investigational Site
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562587    
Other Study ID Numbers: F7HAEM-1503
First Posted: March 26, 2012    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases