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

Omaha, Nebraska 68114

1301

from 91732

Omaha, NE