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

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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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Atlanta, GA
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Fort Worth, Texas 76104
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Fort Worth, TX
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Iowa City, IA
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Long Beach, California 90806
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Long Beach, CA
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New York, New York 10025
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New York, NY
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Washington, DC, District of Columbia 20007
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Washington, DC,
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