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: 12.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)
- Registration Number
- EUCTR2010-023070-40-FR
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- Male
- Target Recruitment
- 16
• Patients with haemophilia B, aged 13-70 years and with a FIX activity of =2%.
• Male patients with moderately severe or severe congenital haemophilia B with a FIX activity =2% according to medical records
• History of at least 150 exposure days to other FIX products
• Scheduled major surgery
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
• Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR interviews
• Current FIX inhibitors =0.6 BU (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 >3 times the upper limit of normal reference ranges at screening (central laboratory)
• Immune modulating or chemotherapeutic medication
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the haemostatic effect of NNC-0156-0000-0009 during surgery procedures in patients with haemophilia B;Secondary Objective: • To evaluate the haemostatic effect of NNC-0156-0000-0009 during surgery and the postoperative period<br>• To evaluate the general safety, including immunogenicity of N9-GP, when used for prevention and treatment of bleeding during surgery and the post-operative period;Primary end point(s): Haemostatic effect during surgery evaluated by the four-point response scale, assessed by the Investigator/Surgeon at the day of surgery<br>- Four-point response scale: Excellent, good, moderate, poor
- Secondary Outcome Measures
Name Time Method