Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B (paradigm™ 3)

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

NCT01386528

U1111-1121-4554 (Other Identifier)

2010-023070-40 (EudraCT Number)

NN7999-3773

Details and patient eligibility

About

This trial is conducted in Africa, Asia, Europe and the United States of America (USA).

The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

Enrollment

13 patients

Sex

Male

Ages

13 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with haemophilia B with a FIX activity below or equal to 2%
Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records
History of at least 150 exposure days to other FIX products
Scheduled major surgery

Exclusion criteria

Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (central laboratory)
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)
ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory)
Immune modulating or chemotherapeutic medication