Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A (guardian ™9)

January 29, 2019 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1756
        • Novo Nordisk Investigational Site
  • Germany
      • Bonn, Germany, 53127
        • Novo Nordisk Investigational Site
      • Hannover, Germany, 30625
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29010
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
      • Vigo, Spain, 36312
        • Novo Nordisk Investigational Site
  • Taiwan
      • Changhua, Taiwan, 500
        • Novo Nordisk Investigational Site
      • Taipei, Taiwan, 100
        • Novo Nordisk Investigational Site
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novo Nordisk Investigational Site
      • Peoria, Illinois, United States, 61615
        • Novo Nordisk Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • Novo Nordisk Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Turoctocog alfa
Drug: turoctocog alfa
Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma FVIII activity at 30 minutes(C30min)
Time Frame: At 30 minutes post-dose
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the FVIII activity-time curve
Time Frame: From 0 up to 72 hours after administration
From 0 up to 72 hours after administration
Incremental recovery FVIII at 30 minutes (IR30min)
Time Frame: At 30 minutes post-dose
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
Terminal half-life (t½) of FVIII
Time Frame: From 0 up to 72 hours after administration
From 0 up to 72 hours after administration
Clearance (CL) of FVIII
Time Frame: From 0 up to 72 hours after administration
From 0 up to 72 hours after administration
Apparent volume of distribution at steady state (Vss) of FVIII
Time Frame: From 0 up to 72 hours after administration
From 0 up to 72 hours after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2016

Primary Completion (Actual)

June 20, 2017

Study Completion (Actual)

June 20, 2017

Study Registration Dates

First Submitted

October 14, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

January 30, 2019

Last Update Submitted That Met QC Criteria

January 29, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7008-4239
  • 2015-004379-56 (EudraCT Number)
  • U1111-1175-1191 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congenital Bleeding Disorder

Clinical Trials on turoctocog alfa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe