Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure in Patients with Haemophilia B
- Conditions
- Haemophilia BMedDRA version: 14.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2010-023072-17-ES
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 75
Previous participation in NN7999-3747 and/or NN7999-3773
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
? Known history of FIX inhibitors based on existing medical records, laboratory report reviews
and patient and LAR interviews
? Current FIX inhibitors ?0.6 BU
? 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 judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with 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