A Study of PEGylated Recombinant Factor VIII (BAX855) in Previously Untreated Young Children With Severe Hemophilia A
Public ClinicalTrials.gov record NCT02615691. 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
Phase 3, Prospective, Multi-center, Open Label Study to Investigate Safety, Immunogenicity and Hemostatic Efficacy of PEGylated Factor VIII (BAX 855) in Previously Untreated Patients (PUPs) < 6 Years With Severe Hemophilia A (FVIII < 1%)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates. The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding. In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand). In case a participant develops antibodies, treatment will be provided as part of the study.
Study identification
- NCT ID
- NCT02615691
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 120 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 5 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
- Nov 12, 2015 (Actual)
- Primary completion
- Oct 29, 2024 (Actual)
- Completion
- Oct 29, 2024 (Actual)
- Last update posted
- Jul 28, 2025
2015 – 2024
United States locations
- U.S. sites
- 20
- U.S. states
- 13
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Kaiser Permanente Oakland M.C. | Cupertino | California | 95014 | — |
| Kaiser Permanente Oakland M.C. | Oakland | California | 94611 | — |
| Kaiser Permanente Oakland M.C. | Roseville | California | 95661 | — |
| UC Davis Health System | Sacramento | California | 95817 | — |
| Connecticut Children's Med Ctr | Hartford | Connecticut | 06106 | — |
| Univ Florida College Medicine | Gainesville | Florida | 17033-0850 | — |
| Center for Advanced Pediatrics | Atlanta | Georgia | 30322 | — |
| Ann & Robert H. Lurie Children's H | Chicago | Illinois | 60611-2605 | — |
| Bleeding and Clotting Dis.Inst. | Peoria | Illinois | 61615 | — |
| UMHS | Ann Arbor | Michigan | 48109-5008 | — |
| New York Presbyterian Hospital | New York | New York | 10065 | — |
| Novant Health Presbyterian Medical Center | Charlotte | North Carolina | 28204 | — |
| Wake Forest Baptist Medical Center | Winston-Salem | North Carolina | 27157 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229-3039 | — |
| Rainbow Babies/Childrens Htl | Cleveland | Ohio | 44106 | — |
| Penn State MS Hershey Med Ctr | Hershey | Pennsylvania | 17033-0850 | — |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
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 71 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02615691, 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 Jul 28, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02615691 live on ClinicalTrials.gov.