Brief Title
Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients
Official Title
A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, Including Pharmacokinetics, of NNC-0156-0000-0009 When Used for Treatment and Prophylaxis of Bleeding Episodes in Patients With Haemophilia B
Brief Summary
This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incidence of Inhibitory Antibodies Against Factor IX Defined as Titre Equal to or Above 0.6 BU (Bethesda Units)
Secondary Outcome
Haemostatic Effect of NNC-0156-0000-0009 When Used for Prophylaxis of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response
Condition
Congenital Bleeding Disorder
Intervention
nonacog beta pegol
Study Arms / Comparison Groups
Prophylaxis, high dose (trial duration 52 weeks)
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
74
Start Date
April 27, 2011
Completion Date
March 31, 2013
Primary Completion Date
March 31, 2013
Eligibility Criteria
Inclusion Criteria: - Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records - History of at least 150 exposure days to other factor IX products - Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis Exclusion Criteria: - Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews - HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL - Congenital or acquired coagulation disorders other than haemophilia B - Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records) - Immune modulating or chemotherapeutic medication
Gender
Male
Ages
13 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01333111
Organization ID
NN7999-3747
Secondary IDs
2010-023069-24
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
June 2017