Cathflo Activase Pediatric Study - Full Text View

Sponsored by:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00307580

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 IV

Drug Information available for: Alteplase Tissue-type plasminogen activator

U.S. FDA Resources

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

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

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

Keywords provided by Genentech:

CVADS

Study placed in the following topic categories:

Fibrin Modulating Agents
Tissue Plasminogen Activator
Fibrinolytic Agents
Cardiovascular Agents
Plasminogen

Additional relevant MeSH terms:

Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Tissue Plasminogen Activator
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009