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

Completed · Phase 1

Conditions studied: Congenital Bleeding Disorder, Haemophilia B

In brief

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.

Key facts

Study ID

NCT00956345

Run by

Novo Nordisk A/S

People needed

18

Starts

2009-08-01

Expected to finish

2010-07-01

Last updated by the study team

2017-01-20

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Portland, Oregon, United States
• Novo Nordisk Investigational Site — Richmond, Virginia, United States
• Novo Nordisk Investigational Site — Copenhagen, Denmark
• Novo Nordisk Investigational Site — Le Kremlin-Bicêtre, France
• Novo Nordisk Investigational Site — Lyon, France
• Novo Nordisk Investigational Site — Berlin, Germany
• Novo Nordisk Investigational Site — Bonn, Germany
• Novo Nordisk Investigational Site — Frankfurt/M., Germany
• Novo Nordisk Investigational Site — Hanover, Germany
• Novo Nordisk Investigational Site — Kashihara-shi, Nara, Japan
• Novo Nordisk Investigational Site — Nagoya-shi, Aichi, Japan
• Novo Nordisk Investigational Site — Nishinomiya-shi, Japan
• Novo Nordisk Investigational Site — Madrid, Spain
• Novo Nordisk Investigational Site — Stockholm, Sweden
• Novo Nordisk Investigational Site — London, United Kingdom
• Novo Nordisk Investigational Site — London, United Kingdom
• Novo Nordisk Investigational Site — Manchester, United Kingdom
• Novo Nordisk Investigational Site — Oxford, United Kingdom

Full record on ClinicalTrials.gov

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