Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Male

Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

Inclusion Criteria:

• Patients with haemophilia B with a FIX activity below or equal to 2%

• Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records

• History of at least 150 exposure days to other FIX products

• Scheduled major surgery

Exclusion Criteria:

• Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews

• Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (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 (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory)

• Immune modulating or chemotherapeutic medication