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Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A
Condition: Hemophilia A · Sponsor: Bioverativ, a Sanofi company
About this study
Primary Objective: \- To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A Secondary Objectives: * To evaluate the efficacy of BIVV001 as a prophylaxis treatment. * To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. * To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes. * To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. * To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes. * To evaluate the safety and tolerability of BIVV001 treatment. * To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B). * To evaluate the efficacy of BIVV001 for perioperative management
This description comes directly from the study's public registry record.
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No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
Locations (85)
| Orthopaedic Institute for Children Site Number : 8400003 | Los Angeles, California, United States | — |
| Children's Hospital Los Angeles Site Number : 8400009 | Los Angeles, California, United States | — |
| University of California San Diego Site Number : 8400007 | San Diego, California, United States | — |
| University of Florida Health Site Number : 8400008 | Gainesville, Florida, United States | — |
| Children's Healthcare of Atlanta Site Number : 8400016 | Atlanta, Georgia, United States | — |
| Rush University Medical Center Site Number : 8400010 | Chicago, Illinois, United States | — |
| Children's Hospital Of Iowa Site Number : 8400011 | Iowa City, Iowa, United States | — |
| University of Michigan Medical Center Site Number : 8400006 | Ann Arbor, Michigan, United States | — |
| Michigan State University School Of Med Site Number : 8400002 | East Lansing, Michigan, United States | — |
| Hemostasis and Thrombosis Center of Nevada Site Number : 8400001 | Las Vegas, Nevada, United States | — |
| New York Presbyterian Hospital/Weill Cornell Medical Center Site Number : 8400017 | New York, New York, United States | — |
| East Carolina University -2390 Hemby Ln Site Number : 8400015 | Greenville, North Carolina, United States | — |
+ 73 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04644575