BAX 326 Pediatric Study (NCT01488994) | Clinical Trial Compass
CompletedPhase 2/3
BAX 326 Pediatric Study
India, Poland, Romania23 participantsStarted 2011-12-20
Plain-language 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 patients.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Main Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events (AEs) Possibly or Probably Related to BAX326
Timeframe: Throughout study period (approximately 17 months)