Study of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A
| Status: | Completed |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 8/30/2018 |
| Start Date: | December 2009 |
| End Date: | May 2011 |
An Open-Label, Crossover, Dose-Escalation, and Multi-Center Study to Determine the Safety, Tolerability, and Pharmacokinetic of a Single Intravenous Injection of rFVIIIFc in Previously Treated Patients With Severe Hemophilia A
The study is to investigate the safety, tolerability, and pharmacokinetics (the determination
of the concentration of the administered drug in blood over time) of recombinant Factor VIII
Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.
of the concentration of the administered drug in blood over time) of recombinant Factor VIII
Fc fusion protein (rFVIIIFc) in previously-treated subjects with severe hemophilia A.
Inclusion Criteria:
1. Male and 12 years of age and older and weigh at least 40 kg
2. Diagnosed with severe hemophilia A (baseline Factor VIII level less than 1%)
3. History of at least 100 exposure days to any Factor VIII product
Exclusion Criteria:
1. History of Factor VIII inhibitors
2. Kidney or liver dysfunction
3. Diagnosed with another coagulation defect other than hemophilia A
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