Status:
COMPLETED
BAX 326 Pediatric Study
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia B
Eligibility:
All Genders
Up to 12 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assess BAX 326 pharmacokinetic parameters, to evaluate its hemostatic efficacy, safety, immunogenicity, and changes in health-related quality of life in pediatric patie...
Detailed Description
The secondary outcome measure: Area Under the Plasma Concentration Versus Time Curve From 0 to 72 Hours (h) Post-infusion analysis was not done due to the different time-points for the last PK blood s...
Eligibility Criteria
Inclusion
- Main
- Participant and/or legal representative has/have voluntarily provided signed informed consent
- Participant has severe (FIX level \< 1%) or moderately severe (FIX level ≤ 2%) hemophilia B
- Participant is \< 12 years old at the time of screening
- Participant has no evidence of a history of FIX inhibitors (based on the participant's medical records)
- Participant is immunocompetent as evidenced by a CD4 count ≥ 200 cells/mm\^3
- Main
Exclusion
- Participant has a detectable FIX inhibitor at screening, with a titer ≥ 0.6 Bethesda Unit (BU)
- Participant has a history of allergic reaction, e.g. anaphylaxis, following exposure to FIX concentrate(s)
- Participant has evidence of an ongoing or recent thrombotic disease
- Participant has an inherited or acquired hemostatic defect other than hemophilia B
Key Trial Info
Start Date :
December 20 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01488994
Start Date
December 20 2011
End Date
May 14 2013
Last Update
May 20 2021
Active Locations (11)
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1
LNJP Maulana Azad Medical College & Associated Hospitals
New Delhi, India, 110002
2
University Pediatric Hospital
Krakow, Poland, 30-663
3
Stanislaw Popowski Provincial Specialist Pediatric Hospital
Olsztyn, Poland, 10-561
4
Professor Tadeusz Sokolowski Independent Public Teaching Hospital of the Pomeranian Medical University in Szczecin
Szczecin, Poland, 71-252