Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
Public ClinicalTrials.gov record NCT01736475. 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 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.
Study identification
- NCT ID
- NCT01736475
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 159 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
- 12 Years to 65 Years
- Sex
- Male
- 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
- Jan 31, 2013 (Actual)
- Primary completion
- Jul 17, 2014 (Actual)
- Completion
- Jul 17, 2014 (Actual)
- Last update posted
- May 20, 2021
2013 – 2014
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Colorado | Aurora | Colorado | 80045 | — |
| University of Florida, College of Medicine | Gainesville | Florida | 32610 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | — |
| Bleeding and Clotting Disorders Institute | Peoria | Illinois | 61614 | — |
| University of Kentucky Medical Center | Lexington | Kentucky | 40504 | — |
| University of Louisville Hospital | Louisville | Kentucky | 40202 | — |
| Tulane University Medical School | New Orleans | Louisiana | 70124 | — |
| Children's Mercy Hospitals & Clinics | Kansas City | Missouri | 66211 | — |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10065 | — |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Palmetto Health | Columbia | South Carolina | 29203 | — |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84132 | — |
| Puget Sound Blood Group | Seattle | Washington | 98104 | — |
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 55 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01736475, 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 20, 2021 · Synced Oct 25, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01736475 live on ClinicalTrials.gov.