Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

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

ID
Name
NN7999-4260
Description
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 arms
Trial start
2017-03-07
Estimated PCD
2017-12-08
Trial end
2017-12-08
Status
Completed
Phase
Early phase I
Treatment
N9-GP
A single dose of 50 IU/kg for intravenous (i.v.) injection
Arms:
N9-GP
ALPROLIX®
A single dose of 50 IU/kg for intravenous (i.v.) injection
Arms:
ALPROLIX®
Size
15
Primary endpoint
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
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}
Updated at
2023-05-26

1 organization

2 products

2 indications

Organization
Novo Nordisk
Product
N9-GP
Indication
Congenital Bleeding Disorder
Indication
Hemophilia B
Product
ALPROLIX®