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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Mar 2017

Geographic Reach

3 countries

12 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

9 months study duration

First Submitted

Initial submission to the registry

March 3, 2017

Completed

4 days until next milestone

Study Start

First participant enrolled

March 7, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2017

Completed

Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

March 3, 2017

Last Update Submit

May 24, 2023

Conditions

Congenital Bleeding Disorder Haemophilia B

Outcome Measures

Primary Outcomes (1)

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
From time 0 (dosing) up to 240 hours post-dose

Secondary Outcomes (17)

Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
From time 0 (dosing) up to 240 hours post-dose
Incremental recovery at 30 minutes (IR30min)
At 30 minutes
Terminal half-life (t½)
From time 0 (dosing) up to 240 hours post-dose
Clearance (CL)
From time 0 (dosing) up to 240 hours post-dose
Area under the activity-time curve
From time 0 (dosing) up to 240 hours post-dose
+12 more secondary outcomes

Study Arms (2)

N9-GP

EXPERIMENTAL

Drug: N9-GP

ALPROLIX®

ACTIVE COMPARATOR

Drug: ALPROLIX®

Interventions

N9-GPDRUG

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

N9-GP

ALPROLIX®DRUG

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

ALPROLIX®

Eligibility Criteria

Age18 Years - 70 Years

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.