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 (paradigm™ 4)

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

NCT01395810

NN7999-3775

U1111-1121-5408 (Other Identifier)

2010-023072-17 (EudraCT Number)

JapicCTI-121812 (Registry Identifier)

Details and patient eligibility

About

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).

Enrollment: 71 patients

Sex: Male

Ages: 13 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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71 participants in 4 patient groups

Prophylaxis, high dose (once weekly)

Experimental group

Treatment:

Drug: nonacog beta pegol

Prophylaxis, low dose (once weekly)

Experimental group

Treatment:

Drug: nonacog beta pegol

On-demand

Experimental group

Treatment:

Drug: nonacog beta pegol

Prophylaxis, high dose (every second week)

Experimental group

Treatment:

Drug: nonacog beta pegol