Cathflo Activase Pediatric Study

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00307580
• Date of registration: 25/03/2006
• Primary sponsor: Genentech
• Public title: Cathflo Activase Pediatric Study
• Scientific title: Cathflo Activase (Alteplase) Pediatric Study (CAPS)
• Date of first enrolment: November 2005
• Target sample size: 300
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00307580
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Contacts

• Name: Martha Blaney, PharmD
• Affiliation: Genentech

Key inclusion & exclusion criteria

Inclusion Criteria:

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 Criteria:

- 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



Age minimum: N/A
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dysfunctional Central Venous Access Devices (CVADS)

Intervention(s)

Drug: Cathflo Activase (Alteplase)

Primary Outcome(s)

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.

Secondary Outcome(s)

To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.

Secondary ID(s)

A2404g

Source(s) of Monetary Support

Please refer to primary and secondary sponsors