A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
NCT ID: NCT03075670
Last Updated: 2023-05-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
15 participants
INTERVENTIONAL
2017-03-07
2017-12-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B
NCT02141074
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
NCT01467427
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients
NCT01333111
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
NCT02137850
An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
NCT03901755
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
N9-GP
N9-GP
A single dose of 50 IU/kg for intravenous (i.v.) injection
ALPROLIX®
ALPROLIX®
A single dose of 50 IU/kg for intravenous (i.v.) injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
N9-GP
A single dose of 50 IU/kg for intravenous (i.v.) injection
ALPROLIX®
A single dose of 50 IU/kg for intravenous (i.v.) injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
70 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novo Nordisk A/S
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Novo Nordisk Investigational Site
Mörfelden-Walldorf, , Germany
Novo Nordisk Investigational Site
Zurich, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Escuriola Ettingshausen C, Hegemann I, Simpson ML, Cuker A, Kulkarni R, Pruthi RK, Garly ML, Meldgaard RM, Persson P, Klamroth R. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial. Res Pract Thromb Haemost. 2019 Mar 23;3(2):268-276. doi: 10.1002/rth2.12192. eCollection 2019 Apr.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016-001149-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1180-7154
Identifier Type: OTHER
Identifier Source: secondary_id
NN7999-4260
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.