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Cathflo Activase Pediatric Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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.

Tracking Information
First Submitted Date  ICMJE March 25, 2006
First Posted Date  ICMJE March 28, 2006
Last Update Posted Date April 9, 2014
Study Start Date  ICMJE April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2006)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 25, 2006)
To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cathflo Activase Pediatric Study
Official Title  ICMJE Cathflo Activase (Alteplase) Pediatric Study (CAPS)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE Dysfunctional Central Venous Access Devices (CVADS)
Intervention  ICMJE Drug: Cathflo Activase (Alteplase)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: March 25, 2006)
300
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00307580
Other Study ID Numbers  ICMJE A2404g
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Genentech, Inc.
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Genentech, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Martha Blaney, PharmD Genentech, Inc.
PRS Account Genentech, Inc.
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP