BAX 855 Pediatric Study
Public ClinicalTrials.gov record NCT02210091. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3 Prospective, Uncontrolled, Multicenter Study Evaluating Pharmacokinetics, Efficacy, Safety, and Immunogenicity of BAX 855 (PEGylated Full-length Recombinant FVIII) in Previously Treated Pediatric Patients With Severe Hemophilia A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study purpose is: * To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last. * To compare pharmacokinetic (PK) parameters to ADVATE. * To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes. * To evaluate safety and immunogenicity.
Study identification
- NCT ID
- NCT02210091
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 75 participants
Conditions and interventions
Conditions
Interventions
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method Biological
- PEGylated Recombinant Factor VIII Biological
Biological
Eligibility (public fields only)
- Age range
- Up to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 30, 2014
- Primary completion
- Oct 22, 2015
- Completion
- Oct 22, 2015
- Last update posted
- May 23, 2021
2014 – 2015
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| University of Colorado | Denver | Colorado | 80220 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Cornell University | New Hyde Park | New York | 11040 | — |
| New York Presbyterian Hospital-Weill | New York | New York | 10065 | — |
| Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Nationwide Childrens Hospital | Columbus | Ohio | 43205 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| University of Utah | Salt Lake City | Utah | 84108 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 27 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02210091, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 23, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02210091 live on ClinicalTrials.gov.