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

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

NCT03075670•Novo Nordisk A/S

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

MALE

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

Locations (12)

Novo Nordisk Investigational Site

Phoenix, Arizona, United States

Novo Nordisk Investigational Site

Chicago, Illinois, United States

Novo Nordisk Investigational Site

Peoria, Illinois, United States

Novo Nordisk Investigational Site

East Lansing, Michigan, United States

Novo Nordisk Investigational Site

Rochester, Minnesota, United States

Novo Nordisk Investigational Site

Oklahoma City, Oklahoma, United States

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Novo Nordisk Investigational Site

Berlin, Germany

Novo Nordisk Investigational Site

Duisburg, Germany

Novo Nordisk Investigational Site

Hanover, Germany

Key Dates

Start Date

March 7, 2017

Primary Completion Date

December 8, 2017

Completion Date

December 8, 2017

Last Updated

May 26, 2023

Enrollment

15

ACTUAL participants

Conditions

Congenital Bleeding DisorderHaemophilia B

Interventions

N9-GP

DRUG

ALPROLIX®

DRUG

Sponsors

Lead Sponsor

Novo Nordisk A/S

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 26, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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