Cathflo Activase Pediatric Study

Cathflo Activase (Alteplase) Pediatric Study (CAPS)

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.

Study Overview

• Status: Completed
• Conditions: Dysfunctional Central Venous Access Devices (CVADS)
• Intervention / Treatment: Drug: Cathflo Activase (Alteplase)

• Study Type: Interventional
• Enrollment: 300
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Measures

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

Collaborators and Investigators

• Sponsor: Genentech, Inc.
• Investigators: Study Director: Martha Blaney, PharmD, Genentech, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2002
• Study Completion (Actual): May 1, 2003

Study Registration Dates

• First Submitted: March 25, 2006
• First Submitted That Met QC Criteria: March 25, 2006
• First Posted (Estimate): March 28, 2006

Study Record Updates

• Last Update Posted (Estimate): April 9, 2014
• Last Update Submitted That Met QC Criteria: April 8, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: CVADS
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator
• Other Study ID Numbers: A2404g