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NCT02941354 Clinical Trial

Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Congenital Bleeding Disorder Clinical Trial

— guardian ™9  

Official title:
A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02941354
Other study ID # NN7008-4239
Secondary ID 2015-004379-56U1
Status Completed
Phase Phase 1
First received
Last updated
Start date October 10, 2016
Est. completion date June 20, 2017

Study information
Verified date January 2019
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.

Recruitment information / eligibility
Status Completed
Enrollment 35
Est. completion date June 20, 2017
Est. primary completion date June 20, 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male, age at least 18 years at the time of signing informed consent

- History of more than 150 exposure days to any factor VIII products

- Subjects with the diagnosis of congenital haemophilia A with factor VIII activity below 1%, based on medical records

Exclusion Criteria:

- Known history of factor VIII inhibitors

- Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening measured by the Nijmegen modified Bethesda method

- Known congenital or acquired coagulation disorders other than haemophilia A

- Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• turoctocog alfa
Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.

Locations
Country Name City State
Austria Novo Nordisk Investigational Site Wien
Bulgaria Novo Nordisk Investigational Site Sofia
Germany Novo Nordisk Investigational Site Bonn
Germany Novo Nordisk Investigational Site Hannover
Serbia Novo Nordisk Investigational Site Belgrade
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Málaga
Spain Novo Nordisk Investigational Site Valencia
Spain Novo Nordisk Investigational Site Vigo
Taiwan Novo Nordisk Investigational Site Changhua
Taiwan Novo Nordisk Investigational Site Taipei
United States Novo Nordisk Investigational Site Chicago Illinois
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Peoria Illinois
United States Novo Nordisk Investigational Site Richmond Virginia

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Bulgaria,  Germany,  Serbia,  Spain,  Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma FVIII activity at 30 minutes(C30min) Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose At 30 minutes post-dose
Secondary Area under the FVIII activity-time curve From 0 up to 72 hours after administration
Secondary Incremental recovery FVIII at 30 minutes (IR30min) Based on samples taken at pre-dose (-1hour), 15minutes, 30minutes, 1hour, 3hours, 6hours, 9hours, 24hours, 28hours, 48hours, 72hours post-dose At 30 minutes post-dose
Secondary Terminal half-life (t½) of FVIII From 0 up to 72 hours after administration
Secondary Clearance (CL) of FVIII From 0 up to 72 hours after administration
Secondary Apparent volume of distribution at steady state (Vss) of FVIII From 0 up to 72 hours after administration
See also
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Completed NCT02568202 - Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S) N/A
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 NCT01562587 - Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State 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 NCT02241694 - To Quantify the Range of Main Psychosocial Factors Affecting Patients and Caregivers in Their Daily Lives N/A
Completed NCT01238367 - A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543 Phase 1
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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