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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03075670
• Collaborator: (none)
• Enrollment: 15
• Locations: 12
• Arms: 2
• Actual Duration (Months): 9.1
• Patients Per Site: 1.3
• Patients Per Site Per Month: 0.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Bleeding Disorder; Haemophilia B	Drug: N9-GP; Drug: ALPROLIX®	Phase 1

Study Design

• Study Type: Interventional
• 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: Mar 7, 2017
• Actual Primary Completion Date: Dec 8, 2017
• Actual Study Completion Date: Dec 8, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg [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) [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) [At 30 minutes]

   Calculated based on plasma FIX activity measured in blood

3. Terminal half-life (t½) [From time 0 (dosing) up to 240 hours post-dose]

   Calculated based on plasma FIX activity measured in blood

4. Clearance (CL) [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 [From time 0 (dosing) up to 240 hours post-dose]

   Calculated based on plasma FIX activity measured in blood

6. Maximum activity (Cmax) [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) [at 30 minutes]

   Calculated based on plasma FIX activity measured in blood

8. Activity at 168 hours (C168h) [At 168 hours]

   Calculated based on plasma FIX activity measured in blood

9. Incremental recovery at maximum activity (IRCmax) [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) [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) [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) [From time 0 (dosing) up to 240 hours post-dose]

    Calculated based on plasma FIX activity measured in blood

13. Mean residence time (MRT) [From time 0 (dosing) up to 240 hours post-dose]

    Calculated based on plasma FIX activity measured in blood

14. Terminal elimination rate constant [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 [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 [From time 0 (dosing) up to 240 hours post-dose]

    Calculated based on plasma FIX activity measured in blood

17. Number of adverse events [From time 0 (dosing) up to 240 hours post-dose]

    Count and % of Adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Phoenix	Arizona	United States	85016-7710
2	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60612
3	Novo Nordisk Investigational Site	Peoria	Illinois	United States	61615
4	Novo Nordisk Investigational Site	East Lansing	Michigan	United States	48823
5	Novo Nordisk Investigational Site	Rochester	Minnesota	United States	55905-0001
6	Novo Nordisk Investigational Site	Oklahoma City	Oklahoma	United States	73104
7	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania	United States	19104
8	Novo Nordisk Investigational Site	Berlin		Germany	10249
9	Novo Nordisk Investigational Site	Duisburg		Germany	47051
10	Novo Nordisk Investigational Site	Hannover		Germany	30159
11	Novo Nordisk Investigational Site	Mörfelden-Walldorf		Germany	64546
12	Novo Nordisk Investigational Site	Zürich		Switzerland	8091

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT03075670
• Other Study ID Numbers: NN7999-4260; 2016-001149-25; U1111-1180-7154
• First Posted: Mar 9, 2017
• Last Update Posted: Nov 22, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders

Study Results

No Results Posted as of Nov 22, 2019