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Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A (alleviate 1)

This study is currently recruiting participants.
Verified October 2017 by Novo Nordisk A/S
Sponsor:
ClinicalTrials.gov Identifier:
NCT02994407
First Posted: December 15, 2016
Last Update Posted: October 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.

Condition Intervention Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa pegol Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety, Tolerability, and Pharmacokinetics Study of Single and Multiple Subcutaneous Doses of Turoctocog Alfa Pegol in Patients With Haemophilia A

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: Day 0-Day 28 ]
    Count and % of Adverse events


Secondary Outcome Measures:
  • Cmax [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Incidence of FVIII inhibitors above or equal to 0.6 BU [ Time Frame: Day 0-Day 28 ]
    Count of presence of inhibitors

  • Area under the activity time curve from 0 to infinity [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Area under the activity time curve from 0 to t [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Area under the activity time curve from 0 to last [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • tmax- time to maximal FVIII activity [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Cmin -the minimal FVIII activity [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • tmin - time to minimal FVIII activity [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Css, min - the minimum FVIII activity at steady state [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Css, max - the maximal FVIII activity at steady state [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Css - the mean FVIII activity at steady state [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Racc - accumulation ratio [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • t½ - terminal half-life [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • CL - total plasma clearance of drug after intravenous administration [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Vz -apparent volume of distribution during terminal phase [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Vss - apparent volume of distribution during steady state [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • MRT - mean residence time [ Time Frame: 0-144 hours ]
    Calculated based on plasma FVIII activity measured in blood.

  • Injection site reactions [ Time Frame: Day 0 - day 28 ]
    Count of reactions

  • Number of treatment requiring bleeding episodes [ Time Frame: Day 0 - day 120 ]
    Count of episodes

  • Consumption of FVIII [ Time Frame: Day 0 - day 120 ]
    Measured in IU

  • Change in Coagulation parameters, fibrinogen [ Time Frame: Day 0, day 7 ]
    Measured in g/L

  • Change in Coagulation parameters, antithrombin [ Time Frame: Day 0, day 7 ]
    Measured in %

  • Change in Coagulation parameters, international normalised ratio [ Time Frame: Day 0, day 7 ]
    Measured in INR

  • Change in Coagulation parameters, activated partial thromboplastin time [ Time Frame: Day 0, day 7 ]
    Measured in sec.

  • Change in Coagulation parameters, von Willebrand Factor [ Time Frame: Day 0, day 7 ]
    Measured in %


Estimated Enrollment: 48
Actual Study Start Date: January 30, 2017
Estimated Study Completion Date: December 31, 2018
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N8-GP s.c. Drug: turoctocog alfa pegol

Part A: Participants will receive a single dose of turoctocog alfa pegol, administered subcutaneously (under the skin), at a dose of 12.5, 25 or 50 U/kg.

Part B: Participants will receive a daily dose of turoctocog alfa pegol, as identified in Part A, as a subcutaneous (under the skin) injection for a period of 3 months.


  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, age above or equal to 18 years at the time of signing informed consent,(part A).
  • Male, age above or equal to 12 years at the time of signing informed consent,(part B).
  • Diagnosis of congenital haemophilia A based on medical records (FVIII activity <1%).
  • History of more than 150 exposure days to any FVIII containing products.

Exclusion Criteria:

  • Previous participation in this trial. Participation is defined as signed informed consent.

(Patients who have completed part A are allowed to also participate in part B. If so, a separate informed consent covering part B must be signed.)

  • Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load greater than or equal to 400.000 copies/mL and/or cluster of differentiation 4+ (CD4+) lymphocyte count less than or equal to 200/μL performed at screening or defined by medical records no older than 6 months)
  • Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
  • Inhibitors to FVIII (greater than or equal to 0.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02994407


Contacts
Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
United States, Florida
Novo Nordisk Investigational Site Recruiting
Orlando, Florida, United States, 32827
United States, Michigan
Novo Nordisk Investigational Site Recruiting
East Lansing, Michigan, United States, 48823
United States, Ohio
Novo Nordisk Investigational Site Not yet recruiting
Cleveland, Ohio, United States, 44106
Novo Nordisk Investigational Site Recruiting
Dayton, Ohio, United States, 45404
United States, South Carolina
Novo Nordisk Investigational Site Not yet recruiting
Charleston, South Carolina, United States, 29425-0001
United States, Wisconsin
Novo Nordisk Investigational Site Recruiting
Milwaukee, Wisconsin, United States, 53226
Austria
Novo Nordisk Investigational Site Recruiting
Innsbruck, Austria, A 6020
Novo Nordisk Investigational Site Recruiting
Wien, Austria, 1090
France
Novo Nordisk Investigational Site Recruiting
Nantes Cedex 1, France, 44093
Germany
Novo Nordisk Investigational Site Recruiting
Berlin, Germany, 10249
Novo Nordisk Investigational Site Recruiting
Duisburg, Germany, 47051
Novo Nordisk Investigational Site Recruiting
Homburg, Germany, 66421
Japan
Novo Nordisk Investigational Site Recruiting
Shinjuku-ku, Tokyo, Japan, 160 0023
Novo Nordisk Investigational Site Recruiting
Suginami-ku, Tokyo, Japan, 167 0035
Serbia
Novo Nordisk Investigational Site Not yet recruiting
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site Recruiting
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site Not yet recruiting
Belgrade, Serbia, 11070
Novo Nordisk Investigational Site Not yet recruiting
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Novo Nordisk A/S
  More Information

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02994407     History of Changes
Other Study ID Numbers: NN7170-4213
U1111-1183-5111 ( Other Identifier: WHO )
2016-002396-99 ( EudraCT Number )
JapicCTI-173683 ( Registry Identifier: JAPIC )
First Submitted: December 13, 2016
First Posted: December 15, 2016
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hemophilia A
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants