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

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.
 
ClinicalTrials.gov Identifier: NCT03075670
Recruitment Status : Completed
First Posted : March 9, 2017
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date  ICMJE March 3, 2017
First Posted Date  ICMJE March 9, 2017
Last Update Posted Date November 22, 2019
Actual Study Start Date  ICMJE March 7, 2017
Actual Primary Completion Date December 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • 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 ]
    Calculated based on plasma FIX activity measured in blood
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Official Title  ICMJE A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Congenital Bleeding Disorder
  • Haemophilia B
Intervention  ICMJE
  • Drug: N9-GP
    A single dose of 50 IU/kg for intravenous (i.v.) injection
  • Drug: ALPROLIX®
    A single dose of 50 IU/kg for intravenous (i.v.) injection
Study Arms  ICMJE
  • Experimental: N9-GP
    Intervention: Drug: N9-GP
  • Active Comparator: ALPROLIX®
    Intervention: Drug: ALPROLIX®
Publications * Escuriola Ettingshausen C, Hegemann I, Simpson ML, Cuker A, Kulkarni R, Pruthi RK, Garly ML, Meldgaard RM, Persson P, Klamroth R. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial. Res Pract Thromb Haemost. 2019 Mar 23;3(2):268-276. doi: 10.1002/rth2.12192. eCollection 2019 Apr.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2017)
15
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2017)
14
Actual Study Completion Date  ICMJE December 8, 2017
Actual Primary Completion Date December 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Switzerland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03075670
Other Study ID Numbers  ICMJE NN7999-4260
2016-001149-25 ( EudraCT Number )
U1111-1180-7154 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Novo Nordisk A/S
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP