Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Subjects With Severe Hemophilia A
Public ClinicalTrials.gov record NCT01181128. 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-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objectives of this study are: to evaluate the safety and tolerability of rFVIIIFc administered as a prophylaxis (Arm 1), weekly (Arm 2), on-demand (Arm 3), and surgical treatment regimen; to evaluate the efficacy of the rFVIIIFc tailored prophylaxis regimen (Arm 1); to evaluate the efficacy of rFVIIIFc administered as an on-demand (Arm 3) and surgical treatment regimen. The secondary objectives of this study are: to characterize the PK profile of rFVIIIFc and compare the PK of rFVIIIFc with the currently marketed product, Advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.
Study identification
- NCT ID
- NCT01181128
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 165 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 12 Years and older
- 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
- Nov 2010 (Type not available)
- Primary completion
- Aug 2012 (Actual)
- Completion
- Aug 2012 (Actual)
- Last update posted
- Jan 8, 2021
2010 – 2012
United States locations
- U.S. sites
- 21
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | — | — |
| Research Site | Los Angeles | California | — | — |
| Research Site | Orange | California | — | — |
| Research Site | Sacramento | California | — | — |
| Research Site | San Diego | California | — | — |
| Research Site | Washington D.C. | District of Columbia | — | — |
| Research Site | Indianapolis | Indiana | — | — |
| Research Site | Iowa City | Iowa | — | — |
| Research Site | Louisville | Kentucky | — | — |
| Research Site | New Orleans | Louisiana | — | — |
| Research Site | Boston | Massachusetts | — | — |
| Research Site | East Lansing | Michigan | — | — |
| Research Site | Las Vegas | Nevada | — | — |
| Research Site | New York | New York | — | — |
| Research Site | Chapel Hill | North Carolina | — | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Philadelphia | Pennsylvania | 19107 | — |
| Research Site | Pittsburgh | Pennsylvania | — | — |
| Research Site | Houston | Texas | — | — |
| Research Site | Salt Lake City | Utah | — | — |
| Research Site | Seattle | Washington | — | — |
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 43 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01181128, 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 Jan 8, 2021 · Synced Oct 18, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01181128 live on ClinicalTrials.gov.