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Completed

NCT Number: NCT03075670

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

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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

N9-GP

Drug

A single dose of 50 IU/kg for intravenous (i.v.) injection

ALPROLIX®

Drug

A single dose of 50 IU/kg for intravenous (i.v.) injection

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

Acronym: paradigm™7

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2017
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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