Cathflo Activase Pediatric Study

This study has been completed.

Sponsor:

Information provided by:

Genentech

ClinicalTrials.gov Identifier:

NCT00307580

First received: March 25, 2006

Last updated: March 6, 2007

Last verified: March 2007

History of Changes

Purpose

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.

Condition	Intervention	Phase
Dysfunctional Central Venous Access Devices (CVADS)	Drug: Cathflo Activase (Alteplase)	Phase 4

Study Type:	Interventional
Study Design:	Primary Purpose: Treatment
Official Title:	Cathflo Activase (Alteplase) Pediatric Study (CAPS)

Resource links provided by NLM:

Drug Information available for: Alteplase

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

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:

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

Estimated Enrollment:

300

Eligibility

Ages Eligible for Study:	up to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00307580

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Martha Blaney, PharmD

Genentech

More Information

Additional Information:

Study Results This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier:	NCT00307580 History of Changes
Other Study ID Numbers:	A2404g
Study First Received:	March 25, 2006
Last Updated:	March 6, 2007
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

CVADS

Additional relevant MeSH terms:

Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on June 18, 2013

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