An Open-label Safety, Efficacy and Pharmacokinetic Study of a Recombinant FVIII Compared to Recombinant Human Antihemophilic FVIII in Patients With Severe Hemophilia A
Public ClinicalTrials.gov record NCT01486927. 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 I/III Open-label, Multicenter, Crossover Safety, Efficacy and Pharmacokinetic Study of Recombinant Coagulation Factor VIII (rFVIII) Compared to Recombinant Human Antihaemophilic Factor VIII (rFVIII; INN: Octocog Alfa) in Subjects With Hemophilia A, and a Repeat PK, Safety and Efficacy Study
Study identification
- NCT ID
- NCT01486927
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- CSL Behring
- Industry
- Enrollment
- 175 participants
Conditions and interventions
Conditions
Interventions
- rVIII-SingleChain Biological
- Octocog alfa 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, 2012
- Primary completion
- Nov 30, 2014
- Completion
- Nov 30, 2014
- Last update posted
- Aug 8, 2016
2012 – 2014
United States locations
- U.S. sites
- 9
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Study Site | Sacramento | California | 95817 | — |
| Study Site | San Diego | California | 92103 | — |
| Study Site | Aurora | Colorado | 80045 | — |
| Study Site | Hartford | Connecticut | 06106 | — |
| Study Site | Miami | Florida | 33136 | — |
| Study Site | Chicago | Illinois | 60612-3833 | — |
| Study Site | New Orleans | Louisiana | 70112 | — |
| Study Site | Houston | Texas | 77030 | — |
| Study 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 47 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01486927, 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 Aug 8, 2016 · Synced Jul 21, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01486927 live on ClinicalTrials.gov.