drugset / Trial / NCT02764489
FEIBA Reconstitution Volume Reduction and Faster Infusion Study (FEIBA STAR)
Phase 3
Completed
45 enrolled
Baxalta now part of Shire
Baxalta Innovations GmbH, now part of Shire · collab
RandomizedCrossoverOpen-labelTreatment
Summary
The purpose of this study is to: * 1\. To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min * 2\. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the regular volume
Timeline
- Start
- 2019-02-12
- Primary completion
- 2021-12-27
- Completion
- 2021-12-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Factor VIII Inhibitor Bypassing Activity | Unknown | 85 iu/kg | — |