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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:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01562587
First received: March 22, 2012
Last updated: May 24, 2012
Last verified: May 2012
History of Changes
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the concentration curve from 0-12 hours [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CL, the total body clearance [ Designated as safety issue: No ]
  • Cmax, the maximum concentration [ Designated as safety issue: No ]
  • tmax, the time to maximum concentration [ Designated as safety issue: No ]
  • t1/2, the terminal half-life [ Designated as safety issue: No ]
  • Area under the concentration curve from time 0-infinity [ Designated as safety issue: No ]
  • Vss, the apparent volume of distribution at steady state [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: No ]

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

Ages Eligible for Study:   3 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01562587

Locations
Germany
Bremen, Germany, 28205
Greece
Athens, Greece, GR-11527
Italy
Firenze, Italy, 50134
Spain
Madrid, Spain, 28046
United Kingdom
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Peter B. Schelde, MSc Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01562587     History of Changes
Other Study ID Numbers: F7HAEM-1503
Study First Received: March 22, 2012
Last Updated: May 24, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Spain: Spanish Agency of Medicines
Italy: The Italian Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hemorrhagic Disorders
Hemophilia B
Hemophilia A
Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Blood Coagulation Disorders, Inherited
 Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Pathologic Processes
Factor VIII
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013