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

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ClinicalTrials.gov Identifier: NCT02994407
Recruitment Status : Completed
First Posted : December 15, 2016
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa pegol Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
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.





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


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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
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.

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


Locations
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United States, Florida
Novo Nordisk Investigational Site
Orlando, Florida, United States, 32827
United States, Iowa
Novo Nordisk Investigational Site
Iowa City, Iowa, United States, 52242
United States, Michigan
Novo Nordisk Investigational Site
East Lansing, Michigan, United States, 48823
United States, Ohio
Novo Nordisk Investigational Site
Cleveland, Ohio, United States, 44106
Novo Nordisk Investigational Site
Dayton, Ohio, United States, 45404
United States, South Carolina
Novo Nordisk Investigational Site
Charleston, South Carolina, United States, 29425-0001
United States, Virginia
Novo Nordisk Investigational Site
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Novo Nordisk Investigational Site
Milwaukee, Wisconsin, United States, 53226
Austria
Novo Nordisk Investigational Site
Innsbruck, Austria, A 6020
Novo Nordisk Investigational Site
Wien, Austria, 1090
France
Novo Nordisk Investigational Site
Nantes Cedex 1, France, 44093
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10249
Novo Nordisk Investigational Site
Duisburg, Germany, 47051
Novo Nordisk Investigational Site
Homburg, Germany, 66421
Japan
Novo Nordisk Investigational Site
Shinjuku-ku, Tokyo, Japan, 160 0023
Novo Nordisk Investigational Site
Suginami-ku, Tokyo, Japan, 167 0035
Serbia
Novo Nordisk Investigational Site
Belgrade, Serbia, 11000
Novo Nordisk Investigational Site
Belgrade, Serbia, 11070
Novo Nordisk Investigational Site
Novi Sad, Serbia, 21000
Sponsors and Collaborators
Novo Nordisk A/S

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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 Posted: December 15, 2016    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants