Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773

Completed · Phase 3

Conditions studied: Congenital Bleeding Disorder, Haemophilia B

In brief

This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B. This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).

Key facts

Study ID

NCT01395810

Run by

Novo Nordisk A/S

People needed

71

Starts

2012-04-15

Expected to finish

2014-03-30

Last updated by the study team

2018-05-09

Who can join

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

You may qualify if…

• Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773

You may not qualify if…

• Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
• Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units)
• Congenital or acquired coagulation disorders other than haemophilia B
• 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)
• Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome

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 — Jacksonville, Florida, United States
• Novo Nordisk Investigational Site — Augusta, Georgia, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Baltimore, Maryland, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — Omaha, Nebraska, United States
• Novo Nordisk Investigational Site — Newark, New Jersey, United States
• Novo Nordisk Investigational Site — New York, New York, 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 — Bron, France
• Novo Nordisk Investigational Site — Le Kremlin-Bicêtre, 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

Full record on ClinicalTrials.gov

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