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

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S

Criteria

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