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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia B

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
N9-GP
ALPROLIX®
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

N9-GP

ALPROLIX®

Arm Description

Outcomes

Primary Outcome Measures

Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
Calculated based on plasma FIX activity measured in blood

Secondary Outcome Measures

Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
Calculated based on plasma FIX activity measured in blood
Incremental recovery at 30 minutes (IR30min)
Calculated based on plasma FIX activity measured in blood
Terminal half-life (t½)
Calculated based on plasma FIX activity measured in blood
Clearance (CL)
Calculated based on plasma FIX activity measured in blood
Area under the activity-time curve
Calculated based on plasma FIX activity measured in blood
Maximum activity (Cmax)
Calculated based on plasma FIX activity measured in blood
Activity at 30 minutes (C30min)
Calculated based on plasma FIX activity measured in blood
Activity at 168 hours (C168h)
Calculated based on plasma FIX activity measured in blood
Incremental recovery at maximum activity (IRCmax)
Calculated based on plasma FIX activity measured in blood
Time of maximum activity (tmax)
Calculated based on plasma FIX activity measured in blood
Apparent volume of distribution during terminal phase (Vz)
Calculated based on plasma FIX activity measured in blood
Apparent volume of distribution at steady-state (Vss)
Calculated based on plasma FIX activity measured in blood
Mean residence time (MRT)
Calculated based on plasma FIX activity measured in blood
Terminal elimination rate constant
Calculated based on plasma FIX activity measured in blood
Area under the activity-time curve from 0 to infinity
Calculated based on plasma FIX activity measured in blood
Area under the activity-time curve from 0 to t last
Calculated based on plasma FIX activity measured in blood
Number of adverse events
Count and % of Adverse events

Full Information

First Posted
March 3, 2017
Last Updated
May 24, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03075670
Brief Title
A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Acronym
paradigm™7
Official Title
A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
March 7, 2017 (Actual)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia B

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
N9-GP
Arm Type
Experimental
Arm Title
ALPROLIX®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
N9-GP
Intervention Description
A single dose of 50 IU/kg for intravenous (i.v.) injection
Intervention Type
Drug
Intervention Name(s)
ALPROLIX®
Intervention Description
A single dose of 50 IU/kg for intravenous (i.v.) injection
Primary Outcome Measure Information:
Title
Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Secondary Outcome Measure Information:
Title
Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Incremental recovery at 30 minutes (IR30min)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
At 30 minutes
Title
Terminal half-life (t½)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Clearance (CL)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Area under the activity-time curve
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Maximum activity (Cmax)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Activity at 30 minutes (C30min)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
at 30 minutes
Title
Activity at 168 hours (C168h)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
At 168 hours
Title
Incremental recovery at maximum activity (IRCmax)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Time of maximum activity (tmax)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Apparent volume of distribution during terminal phase (Vz)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Apparent volume of distribution at steady-state (Vss)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Mean residence time (MRT)
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Terminal elimination rate constant
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Area under the activity-time curve from 0 to infinity
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Area under the activity-time curve from 0 to t last
Description
Calculated based on plasma FIX activity measured in blood
Time Frame
From time 0 (dosing) up to 240 hours post-dose
Title
Number of adverse events
Description
Count and % of Adverse events
Time Frame
From time 0 (dosing) up to 240 hours post-dose

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Berlin
ZIP/Postal Code
10249
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Duisburg
ZIP/Postal Code
47051
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Hannover
ZIP/Postal Code
30159
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Mörfelden-Walldorf
ZIP/Postal Code
64546
Country
Germany
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Citations:
PubMed Identifier
31011711
Citation
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.
Results Reference
derived

Learn more about this trial

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

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