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

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia B

In brief

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.

Key facts

Study ID

NCT01386528

Run by

Novo Nordisk A/S

People needed

13

Starts

2012-06-07

Expected to finish

2013-12-01

Last updated by the study team

2017-08-23

Who can join

Age: 13 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — San Francisco, California, United States
• Novo Nordisk Investigational Site — Washington D.C., District of Columbia, United States
• Novo Nordisk Investigational Site — Augusta, Georgia, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Syracuse, New York, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Vienna, Austria
• Novo Nordisk Investigational Site — Le Kremlin-Bicêtre, France
• Novo Nordisk Investigational Site — Lyon, France
• Novo Nordisk Investigational Site — Bonn, Germany
• Novo Nordisk Investigational Site — Duisburg, Germany
• Novo Nordisk Investigational Site — Giessen, Germany
• Novo Nordisk Investigational Site — Hanover, Germany
• Novo Nordisk Investigational Site — Athens, Greece
• Novo Nordisk Investigational Site — Florence, Italy
• Novo Nordisk Investigational Site — Milan, Italy
• Novo Nordisk Investigational Site — Kashihara-shi, Nara, Japan
• Novo Nordisk Investigational Site — Kawasaki-shi, Kanagawa, Japan
• Novo Nordisk Investigational Site — Nagoya-shi, Aichi, Japan
• Novo Nordisk Investigational Site — Nishinomiya-shi, Japan
• Novo Nordisk Investigational Site — Suginami-ku, Tokyo, Japan
• Novo Nordisk Investigational Site — Tokyo, Japan
• Novo Nordisk Investigational Site — Kuala Lumpur, Malaysia
• Novo Nordisk Investigational Site — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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