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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 A/S
ClinicalTrials.gov Identifier:
NCT01562587
First received: March 22, 2012
Last updated: May 24, 2012
Last verified: May 2012
  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:


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

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
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: 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 A/S
Investigators
Study Director: Peter B. Schelde, MSc 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: 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
Hemophilia A
Hemophilia B
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Cardiovascular Diseases
Coagulation Protein Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Hematologic Diseases
Hemorrhagic Disorders
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014