Status:
COMPLETED
Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia B
Eligibility:
MALE
18-65 years
Phase:
PHASE1
Brief 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 concentrati...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00956345
Start Date
August 1 2009
End Date
July 1 2010
Last Update
January 20 2017
Active Locations (19)
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1
Novo Nordisk Investigational Site
Cincinnati, Ohio, United States, 45229
2
Novo Nordisk Investigational Site
Portland, Oregon, United States, 97239
3
Novo Nordisk Investigational Site
Richmond, Virginia, United States, 23219
4
Novo Nordisk Investigational Site
Copenhagen, Denmark, 2100