Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia B; Congenital Bleeding Disorder

Treatments: Drug: nonacog beta pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00956345

090857 (Registry Identifier)

2009-011085-28 (EudraCT Number)

NN7999-3639

Details and patient eligibility

About

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

The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.

Enrollment: 18 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with haemophilia B (baseline level of Factor IX less than or equal to 2%)
• History of at least 150 exposure days to any Factor IX products
• Body Mass Index (BMI) below 30.0 kg/m2 (inclusive)

Exclusion criteria

• History of Factor IX inhibitors
• Platelet count less than 50,000 platelets/microlitre (assessed by laboratory)
• Kidney or liver dysfunction
• Scheduled surgery requiring Factor IX replacement therapy, during the trial period

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

25U/kg

Experimental group

Treatment:

Drug: nonacog beta pegol

Drug: nonacog beta pegol

Drug: nonacog beta pegol

50U/kg

Experimental group

Treatment:

Drug: nonacog beta pegol

Drug: nonacog beta pegol

Drug: nonacog beta pegol

100U/kg

Experimental group

Treatment:

Drug: nonacog beta pegol

Drug: nonacog beta pegol

Drug: nonacog beta pegol