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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia B; Congenital Bleeding Disorder

Treatments: Drug: ALPROLIX®; Drug: N9-GP

Study type: Interventional

Funder types: Industry

Identifiers

NCT03075670

U1111-1180-7154 (Other Identifier)

NN7999-4260

2016-001149-25 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

N9-GP

Experimental group

Treatment:

Drug: N9-GP

ALPROLIX®

Active Comparator group

Treatment:

Drug: ALPROLIX®