Brief Title
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
Official Title
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B
Brief Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with Haemophilia B.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incidence of Inhibitory Antibodies Against Coagulation Factor IX (FIX) Defined as Titre Above or Equal to 0.6 Bethesda Units (BU)
Secondary Outcome
Number of Bleeding Episodes During Prophylaxis
Condition
Congenital Bleeding Disorder
Intervention
nonacog beta pegol
Study Arms / Comparison Groups
NNC-0156-000-0009
Description:
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
25
Start Date
May 16, 2012
Completion Date
November 30, 2023
Primary Completion Date
March 30, 2014
Eligibility Criteria
Inclusion Criteria: - Male patients with moderately severe or severe congenital haemophilia B with a Factor IX activity level below or equal to 2% according to medical records - Age below or equal to 12 years (until patient turns 13 years, at time of inclusion) - Body weight above or equal to 10 kg - History of at least 50 exposure days (EDs) to other FIX products - The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an electronic diary (eDiary), capable of conducting home treatment and otherwise able to follow trial procedures Exclusion Criteria: - Known history of FIX inhibitors - Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU) - Congenital or acquired coagulation disorder other than haemophilia B - Platelet count below 50,000/mcL at screening - Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference ranges at screening - Creatinine level above or equal to 1.5 times above the upper normal limit of normal reference ranges at screening - Human immunodeficiency virus (HIV) positive, defined by medical records, and with a CD4+ lymphocyte count below or equal to 200/mcL - Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids) - Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)
Gender
Male
Ages
N/A - 12 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01467427
Organization ID
NN7999-3774
Secondary IDs
2011-000826-31
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
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Verification Date
June 2020