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

Phase 1

• Conditions: Haemophilia B; MedDRA version: 12.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)

• Registration Number: EUCTR2010-023069-24-FR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-31
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: Male
• Target Recruitment: 72

Inclusion Criteria

• 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 on prophylaxis or 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
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

Exclusion Criteria

• 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, defined by medical records with 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