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Cathflo Activase Pediatric Study

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ClinicalTrials.gov Identifier: NCT00307580
Recruitment Status : Completed
First Posted : March 28, 2006
Last Update Posted : April 9, 2014
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

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 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 or disease Intervention/treatment Phase
Dysfunctional Central Venous Access Devices (CVADS) Drug: Cathflo Activase (Alteplase) Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 300 participants
Primary Purpose: Treatment
Official Title: Cathflo Activase (Alteplase) Pediatric Study (CAPS)
Study Start Date : April 2002
Actual Study Completion Date : May 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase




Primary Outcome Measures :
  1. 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 :
  1. To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.


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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307580


Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Martha Blaney, PharmD Genentech, Inc.

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00307580     History of Changes
Other Study ID Numbers: A2404g
First Posted: March 28, 2006    Key Record Dates
Last Update Posted: April 9, 2014
Last Verified: April 2014

Keywords provided by Genentech, Inc.:
CVADS

Additional relevant MeSH terms:
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action