Status:
COMPLETED
Cathflo Activase Pediatric Study
Lead Sponsor:
Genentech, Inc.
Conditions:
Dysfunctional Central Venous Access Devices (CVADS)
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
Brief Summary
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 cat...
Eligibility Criteria
Inclusion
- Subjects had to meet the following inclusion criteria to be eligible for study entry:
- Less than 17 years of age
- Clinically stable
- Occlusion of CVAD (including catheters with valves, multiple lumens, umbilical catheters, and implanted ports)
- For subjects who weighed \>= 10 kg, inability to withdraw 3 mL of blood from the CVAD
- For subjects who weighed \< 10 kg, inability to withdraw 1 mL of blood from the CVAD
- Ability to infuse fluids at the volume necessary to instill Cathflo Activase into the CVAD
- Written informed consent and assent (if appropriate) provided by parent or legal guardian and compliance with study assessments for the full duration of the study
Exclusion
- Ability to withdraw blood following subject repositioning
- CVAD insertion \< 48 hours prior to enrollment
- Selected study catheter implanted specifically for hemodialysis
- Evidence of mechanical, non-thrombotic occlusion of the CVAD (e.g., kink in the CVAD or suture constricting the catheter)
- Previous enrollment in this study
- Use of fibrinolytic agent (e.g., alteplase, reteplase, tenecteplase, urokinase, streptokinase) within 24 hours of enrollment
- At high risk for bleeding events, embolic complications (i.e., recent pulmonary embolism, deep vein thrombosis, endarterectomy, clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constituted a significant hazard
- Known hypersensitivity to alteplase or any component of the formulation
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
May 1 2003
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00307580
Start Date
April 1 2002
End Date
May 1 2003
Last Update
April 9 2014
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