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

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Disease Information

Descriptive Information
Brief Title † A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
Official Title † A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
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.
Detailed Description
Study Phase Phase 1
Study Type † Interventional
Study Design †
Primary Outcome Measure † Area under the factor IX activity-time curve from 0 to infinity dose-normalised to 50 IU/kg
Secondary Outcome Measure † Maximum activity dose-normalised to 50 IU/kg (Cmax,norm)
Condition † Congenital Bleeding Disorder Haemophilia B
Intervention † DrugN9-GP
Study Arms / Comparison Groups N9-GP ALPROLIX®
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 14
Start Date † March 7, 2017
Completion Date December 18, 2017
Primary Completion Date June 26, 2017
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
Gender Male
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Novo Nordisk, (+1) 866-867-7178, clinicaltrials@novonordisk.com
Location Countries † Germany
Administrative Information
NCT ID † NCT03075670
Organization ID NN7999-4260
Secondary IDs †† 2016-001149-25, U1111-1180-7154
Responsible Party Sponsor
Study Sponsor † Novo Nordisk A/S
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date June 2017
First Received Date † March 3, 2017
Last Updated Date June 16, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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