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

• Conditions: Haemophilia B; MedDRA version: 14.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2010-023070-40-ES
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-29
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 16

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
? Scheduled major surgery
Are the trial subjects under 18? yes
Number of subjects for this age range: 2
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

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)
? 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