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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01562587
First Posted: March 26, 2012
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Intervention Phase
Congenital Bleeding Disorder Haemophilia A Haemophilia B Drug: activated recombinant human factor VII Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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

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

Enrollment: 18
Study Start Date: September 2002
Study Completion Date: May 2003
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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
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
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562587     History of Changes
Other Study ID Numbers: F7HAEM-1503
First Submitted: March 22, 2012
First Posted: March 26, 2012
Last Update Posted: January 12, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants