An Open Label Study to Determine the Safety and Efficacy of Replacement Factor VIII Protein (Known as rFVIIIFc) in Previously Untreated Males With Severe Hemophilia A
Public ClinicalTrials.gov record NCT02234323. 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
An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study was to evaluate the safety of rFVIIIFc (BIIB031) in previously untreated participants (PUPs) with severe hemophilia A. The secondary objectives were to evaluate the efficacy of rFVIIIFc in the prevention and treatment of bleeding episodes in PUPs, to evaluate rFVIIIFc consumption for the prevention and treatment of bleeding episodes in PUPs, and to describe experience with the use of rFVIIIFc for immune tolerance induction (ITI) in participants with inhibitors.
Study identification
- NCT ID
- NCT02234323
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 108 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 5 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 12, 2015 (Actual)
- Primary completion
- Sep 23, 2019 (Actual)
- Completion
- Sep 23, 2019 (Actual)
- Last update posted
- Apr 11, 2022
2015 – 2019
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | 72202 | — |
| Research Site | Duarte | California | 91010 | — |
| Research Site | Sacramento | California | 95817 | — |
| Research Site | San Francisco | California | 94143 | — |
| Research Site | Torrance | California | 90509 | — |
| Research Site | Indianapolis | Indiana | 46260 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | Brewer | Maine | 04412 | — |
| Research Site | East Lansing | Michigan | 48823 | — |
| Research Site | Minneapolis | Minnesota | 55404 | — |
| Research Site | St Louis | Missouri | 63104 | — |
| Research Site | Buffalo | New York | 14209 | — |
| Research Site | New York | New York | 10065 | — |
| Research Site | Rochester | New York | 14621 | — |
| Research Site | Columbus | Ohio | 43205 | — |
| Research Site | Portland | Oregon | 97239 | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Dallas | Texas | 75230 | — |
| Research Site | Dallas | Texas | 75235 | — |
| Research Site | Milwaukee | Wisconsin | 53226 | — |
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 51 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02234323, 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 Apr 11, 2022 · 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 NCT02234323 live on ClinicalTrials.gov.