Safety and Efficacy of NNC-0156-0000-0009 in Haemophilia B Patients (paradigm™ 2)

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Haemophilia B

Congenital Bleeding Disorder

Treatments

Drug: nonacog beta pegol

Study type

Interventional

Funder types

Industry

Identifiers

NCT01333111

2010-023069-24 (EudraCT Number)

JapicCTI-111644 (Other Identifier)

NN7999-3747

U1111-1119-6415 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Africa, Asia, Europe, Japan and North America. The aim of this trial is to evaluate the safety and efficacy, including pharmacokinetics (the rate at which the body eliminates the trial drug), of NNC-0156-0000-0009 (nonacog beta pegol) when used for treatment and prophylaxis of bleeding episodes in patients with haemophilia B.

Enrollment

74 patients

Sex

Male

Ages

13 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male patients with moderately severe or severe congenital haemophilia B with a factor IX activity of 2% or below according to medical records
History of at least 150 exposure days to other factor IX products
Patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months, or patients currently on prophylaxis

Exclusion criteria

Known history of factor IX inhibitors based on existing medical records, laboratory report reviews and patient and legally acceptable representative (LAR) interviews
HIV (Human immunodeficiency virus) positive, with a viral load equal to or above 400,000 copies/mL and/or CD4+ lymphocyte count equal to or below 200/microL
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)
Immune modulating or chemotherapeutic medication