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NCT01562587 Clinical Trial

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
Secondary ID
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

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
See also
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Completed NCT01949792 - A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors Phase 1
Completed NCT01205724 - Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A Phase 1
Completed NCT00108797 - Trial of NovoSeven® in Haemophilia - Joint Bleeds Phase 4
Completed NCT01493778 - Safety and Efficacy of Turoctocog Alfa in Prevention and Treatment of Bleeds in Previously Untreated Children With Haemophilia A Phase 3
Completed NCT02490787 - Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects Phase 1
Completed NCT00951405 - Safety and Efficacy of 3 Different Doses of Long Acting Factor VII in Haemophilia A or B Patients With Inhibitors Phase 2
Completed NCT01876745 - A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan N/A
Completed NCT02920398 - A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A Phase 1
Completed NCT00984126 - Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015 Phase 3
Completed NCT01228669 - Safety of NNC 0172-0000-2021 in Healthy Male Subjects and Subjects With Haemophilia A or B Phase 1
Completed NCT01988532 - Impact of Pain on Functional Impairment and Quality of Life in Adults With Hemophilia N/A
Completed NCT01234545 - Observational Study Describing the Usual Clinical Practice Use of NovoSeven® in the Home Treatment of Joint Bleeds in Patients With Haemophilia A or B and Inhibitors N/A
Completed NCT01779921 - Treatment of Congenital Factor VII Deficiency N/A
Completed NCT01563471 - Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers Phase 1
Completed NCT02941354 - Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A Phase 1
Completed NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01220141 - Observational Study on Safety of Room Temperature Stable NovoSeven® in Patients With Haemophilia A or B N/A
Completed NCT01230021 - Safety of a Single Intravenous Dose of Recombinant Factor XIII in Children With Congenital FXIII A-subunit Deficiency Phase 3

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