Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
| Status: | Withdrawn |
|---|---|
| Conditions: | Anemia, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - 64 |
| Updated: | 9/27/2018 |
| Start Date: | April 2005 |
| End Date: | November 2005 |
A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)
The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate,
using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.
using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.
Inclusion Criteria:
- Severe hemophilia A
- Previously treated patients with at least 150 exposure days to any Factor VIII product
Exclusion Criteria:
- Hypersensitivity to any recombinant Factor VIII product
- History of or current Factor VIII inhibitor
- Bleeding episode or other reason requiring Factor VIII treatment within 3 days of
study
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