Brief Title
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
Official Title
An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B
Brief Summary
This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
Secondary Outcome
Consumption of NNC-0156-0000-0009 (U/kg Body Weight)
Condition
Congenital Bleeding Disorder
Intervention
nonacog beta pegol
Study Arms / Comparison Groups
Patients enrolled in trial
Description: New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
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
13
Start Date
June 7, 2012
Completion Date
December 1, 2013
Primary Completion Date
December 1, 2013
Eligibility Criteria
Inclusion Criteria: - Patients with haemophilia B with a FIX activity below or equal to 2% - Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records - History of at least 150 exposure days to other FIX products - Scheduled major surgery Exclusion Criteria: - Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews - Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (central laboratory) - 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) - ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory) - Immune modulating or chemotherapeutic medication
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
NCT01386528
Organization ID
NN7999-3773
Secondary IDs
2010-023070-40
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
July 2017