A Multi-centre, Single-blind Trial Evaluating Safety and Efficacy, including Pharmacokinetics, of NNC-0156-0000-0009 when used for Treatment and Prophylaxis of Bleeding Episodes in Patients with Haemophilia B - paradigm™2
- Conditions
- Haemophilia BMedDRA version: 14.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 10010331 - Congenital, familial and genetic disorders
- Registration Number
- EUCTR2010-023069-24-GB
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 72
• 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
• Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis
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)
• HIV positive with a viral load =400,000 copies/mL and/or CD4+ lymphocyte count =200/µL
• 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)
• Platelet count <50.000 platelets/µl at screening (local laboratory)
• ALT >3 times the upper limit of normal reference ranges at screening (central laboratory)
• Creatinine level =1.5 times above upper normal limit 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 immunogenicity of NNC-0156-0000-0009;Secondary Objective: • To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of<br> NNC-0156-0000-0009<br>• To evaluate clinical efficacy of NNC-0156-0000-0009 in long term bleeding <br> prophylaxis (number of bleeding episodes during prophylaxis)<br>• To evaluate the efficacy of NNC-0156-0000-0009 by the surrogate marker for<br> efficacy, FIX activity<br>• To evaluate general safety of NNC-0156-0000-0009;Primary end point(s): Incidence of inhibitory antibodies against FIX defined as titre =0.6 B
- Secondary Outcome Measures
Name Time Method