Cathflo Activase Pediatric Study
This was a Phase IV, open-label, single-arm, multicenter trial that was to be conducted at ~60 sites in the United States. Approximately 300 pediatric subjects with dysfunctional CVADs (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports) were to be treated with up to two serially instilled doses of Cathflo Activase.
Dysfunctional Central Venous Access Devices (CVADS)
Drug: Cathflo Activase (Alteplase)
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Cathflo Activase (Alteplase) Pediatric Study (CAPS)|
- To evaluate the safety, as measured by the incidence of intracranial hemorrhage during the treatment with Cathflo Activase, in restoring function to dysfunctional CVADs in pediatric populations.
- To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.