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

Status:	Completed
Conditions:	Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	13 - 70
Updated:	5/11/2018
Start Date:	April 15, 2012
End Date:	March 30, 2014

Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B

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).

Inclusion Criteria:

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

Exclusion Criteria:

- 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

We found this trial at

sites

Novo Nordisk Investigational Site

Augusta, Georgia 30912

from

Augusta, GA