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

Congenital Bleeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01562587
• Other study ID #: F7HAEM-1503
• Status: Completed
• Phase: Phase 1
• First received: March 22, 2012
• Last updated: January 11, 2017
• Start date: September 2002
• Est. completion date: May 2003

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGreece: National Organization of MedicinesSpain: Spanish Agency of MedicinesItaly: The Italian Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: May 2003
• Est. primary completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 3 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B
• Hemophilia A
• Hemophilia B
• Hemostatic Disorders

Intervention

Drug:
• activated recombinant human factor VII
A single bolus dose is administered. Injected intravenously
• 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

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Bremen
Germany	Novo Nordisk Investigational Site	Frankfurt
Greece	Novo Nordisk Investigational Site	Athens
Italy	Novo Nordisk Investigational Site	Firenze
Italy	Novo Nordisk Investigational Site	Milano
Spain	Novo Nordisk Investigational Site	Madrid
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Oxford

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Greece,  Italy,  Spain,  United Kingdom, 

References & Publications (1)

Villar A, Aronis S, Morfini M, Santagostino E, Auerswald G, Thomsen HF, Erhardtsen E, Giangrande PL. Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A. Haemophilia. 2004 Jul;10(4):352-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the concentration curve from 0-12 hours			No
Secondary	CL, the total body clearance			No
Secondary	Cmax, the maximum concentration			No
Secondary	tmax, the time to maximum concentration			No
Secondary	t1/2, the terminal half-life			No
Secondary	Area under the concentration curve from time 0-infinity			No
Secondary	Vss, the apparent volume of distribution at steady state			No
Secondary	Adverse events			No

External Links

•   Clinical Trials at Novo Nordisk