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A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B (paradigm™7)

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ClinicalTrials.gov Identifier: NCT03075670
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Europe and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia B Drug: N9-GP Drug: ALPROLIX® Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Actual Study Start Date : March 7, 2017
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: N9-GP Drug: N9-GP
A single dose of 50 IU/kg for intravenous (i.v.) injection

Active Comparator: ALPROLIX® Drug: ALPROLIX®
A single dose of 50 IU/kg for intravenous (i.v.) injection




Primary Outcome Measures :
  1. Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood


Secondary Outcome Measures :
  1. Maximum activity dose-normalised to 50 IU/kg (Cmax,norm) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  2. Incremental recovery at 30 minutes (IR30min) [ Time Frame: At 30 minutes ]
    Calculated based on plasma FIX activity measured in blood

  3. Terminal half-life (t½) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  4. Clearance (CL) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  5. Area under the activity-time curve [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  6. Maximum activity (Cmax) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  7. Activity at 30 minutes (C30min) [ Time Frame: at 30 minutes ]
    Calculated based on plasma FIX activity measured in blood

  8. Activity at 168 hours (C168h) [ Time Frame: At 168 hours ]
    Calculated based on plasma FIX activity measured in blood

  9. Incremental recovery at maximum activity (IRCmax) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  10. Time of maximum activity (tmax) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  11. Apparent volume of distribution during terminal phase (Vz) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  12. Apparent volume of distribution at steady-state (Vss) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  13. Mean residence time (MRT) [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  14. Terminal elimination rate constant [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  15. Area under the activity-time curve from 0 to infinity [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  16. Area under the activity-time curve from 0 to t last [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Calculated based on plasma FIX activity measured in blood

  17. Number of adverse events [ Time Frame: From time 0 (dosing) up to 240 hours post-dose ]
    Count and % of Adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, aged 18-70 years (both inclusive) at the time of signing informed consent
  • Patients with the diagnosis of congenital haemophilia B with factor IX activity below or equal to 2%, based on medical records
  • History of more than 150 exposures days to any factor IX containing products

Exclusion Criteria:

  • Known history of factor IX inhibitors
  • Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the Nijmegen modified Bethesda method
  • Immunocompromised (CD4+ T cells below or equal to 200/μL)
  • Known congenital or acquired coagulation disorders other than haemophilia B
  • Body mass index above 35 kg/m^²

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): NCT03075670


Locations
United States, Arizona
Novo Nordisk Investigational Site
Phoenix, Arizona, United States, 85016-7710
United States, Illinois
Novo Nordisk Investigational Site
Chicago, Illinois, United States, 60612
Novo Nordisk Investigational Site
Peoria, Illinois, United States, 61615
United States, Michigan
Novo Nordisk Investigational Site
East Lansing, Michigan, United States, 48823
United States, Minnesota
Novo Nordisk Investigational Site
Rochester, Minnesota, United States, 55905
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Germany
Novo Nordisk Investigational Site
Berlin, Germany, 10249
Novo Nordisk Investigational Site
Duisburg, Germany, 47051
Novo Nordisk Investigational Site
Hannover, Germany, 30159
Novo Nordisk Investigational Site
Mörfelden-Walldorf, Germany, 64546
Switzerland
Novo Nordisk Investigational Site
Zürich, Switzerland, 8091
Sponsors and Collaborators
Novo Nordisk A/S

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03075670     History of Changes
Other Study ID Numbers: NN7999-4260
2016-001149-25 ( EudraCT Number )
U1111-1180-7154 ( Other Identifier: World Health Organization (WHO) )
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: January 12, 2018
Last Verified: January 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

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

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases