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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03075670
First Posted: March 9, 2017
Last Update Posted: November 14, 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. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  Purpose
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 Intervention Phase
Congenital Bleeding Disorder Haemophilia B Drug: N9-GP Drug: ALPROLIX® Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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

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

  • 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

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

  • 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

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

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

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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

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


Estimated Enrollment: 14
Actual Study Start Date: March 7, 2017
Estimated Study Completion Date: December 18, 2017
Estimated Primary Completion Date: December 18, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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:   18 Years and older   (Adult, Senior)
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
  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): 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
  More Information

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 Submitted: March 3, 2017
First Posted: March 9, 2017
Last Update Posted: November 14, 2017
Last Verified: November 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
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