Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
Status: | Completed |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 13 - 70 |
Updated: | 11/23/2013 |
Start Date: | June 2012 |
End Date: | December 2013 |
Contact: | Novo Nordisk |
Email: | clinicaltrials@novonordisk.com |
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
This trial is conducted in Europe, Japan, South Africa and the United States of America
(USA). The aim of this trial is to evaluate the safety and efficacy of NNC-0156-0000-0009
during surgical procedures in patients with haemophilia B.
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
We found this trial at
6
sites
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