Brief Title
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
Official Title
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B
Brief Summary
This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units)
Secondary Outcome
Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor)
Condition
Congenital Bleeding Disorder
Intervention
nonacog beta pegol
Study Arms / Comparison Groups
Prophylaxis, high dose (once weekly)
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
71
Start Date
April 15, 2012
Completion Date
March 30, 2014
Primary Completion Date
March 30, 2014
Eligibility Criteria
Inclusion Criteria: - Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773 Exclusion Criteria: - Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews - Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units) - 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) - Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome
Gender
Male
Ages
13 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01395810
Organization ID
NN7999-3775
Secondary IDs
2010-023072-17
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
April 2018