Status:
COMPLETED
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia B
Eligibility:
MALE
Up to 12 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Asia, Europe and North America. The aim of the trial is to evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body) of NNC-0156-0000-0009 ...
Eligibility Criteria
Inclusion
- Male patients with moderately severe or severe congenital haemophilia B with a Factor IX activity level below or equal to 2% according to medical records
- Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)
- Body weight above or equal to 10 kg
- History of at least 50 exposure days (EDs) to other FIX products
- The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode, keeping an electronic diary (eDiary), capable of conducting home treatment and otherwise able to follow trial procedures
Exclusion
- Known history of FIX inhibitors
- Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU)
- Congenital or acquired coagulation disorder other than haemophilia B
- Platelet count below 50,000/mcL at screening
- Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference ranges at screening
- Creatinine level above or equal to 1.5 times above the upper normal limit of normal reference ranges at screening
- Human immunodeficiency virus (HIV) positive, defined by medical records, and with a CD4+ lymphocyte count below or equal to 200/mcL
- Immune modulating or chemotherapeutic medication (except single pulse treatment, inhaled and topical steroids)
- Previous arterial thrombotic events (myocardial infarction and intracranial thrombosis, as defined by medical records)
Key Trial Info
Start Date :
May 16 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01467427
Start Date
May 16 2012
End Date
November 17 2023
Last Update
December 23 2025
Active Locations (51)
Enter a location and click search to find clinical trials sorted by distance.
1
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California, United States, 90027
2
UC Davis Medical Center
Sacramento, California, United States, 95817
3
Colorado Hemophilia & Thrombosis Center
Aurora, Colorado, United States, 80045
4
Childrens National Medical Ctr
Washington D.C., District of Columbia, United States, 20010-2978