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 - Paradigm 3
- Conditions
- Haemophilia BMedDRA version: 13.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 10010331 - Congenital, familial and genetic disorders
- Registration Number
- EUCTR2010-023070-40-IT
- Lead Sponsor
- OVO NORDISK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 16
1.Written informed consent from the patient or the child’s parent/legal guardian obtained before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the patient 2.Male patients with moderately severe or severe congenital haemophilia B with a FIX activity =2% according to medical records 3.History of at least 150 exposure days to other FIX products 4.Age 13-70 years (both inclusive) 5.Body Mass Index (BMI) = 35 6.Scheduled major surgery (refer to section 5.2.1 for a definition) 7.The patient and/or LAR is capable of assessing a bleeding episode, keeping a diary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Known or suspected hypersensitivity to trial products or related products 2.Receipt of any investigational drug except N9-GP, within the last 30 days prior to present trial 3.Known history of FIX inhibitors based on available medical record, laboratory report reviews and patient and patient’s LAR interviews 4.Current FIX inhibitors =0.6 BU (central laboratory) 5.HIV positive, defined by medical records with viral load =400,000 copies/mL and/or CD4+ lymphocyte count =200/µL. If the data is not available in medical records within last 6 months, CD4+ will be measured at the screening visit. 6.Congenital or acquired coagulation disorders other than haemophilia B 7.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) 8.Platelet count < 50,000 platelets/µL at screening 9.ALT > 3 times the upper limit of normal reference ranges at screening 10.Creatinine level = 1.5 times above upper normal limit at screening 11.Immune modulating or chemotherapeutic medication. 12.Any disease or condition (liver, kidney and inflammatory disorders included) which, according to the Investigator’s judgement, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method