Cathflo Activase Pediatric Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00307580
First received: March 25, 2006
Last updated: April 8, 2014
Last verified: April 2014

March 25, 2006
April 8, 2014
April 2002
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00307580 on ClinicalTrials.gov Archive Site
To estimate the rate of restoration of function to dysfunctional CVADs following administration of up to two instillations of Cathflo Activase.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 4
Primary Purpose: Treatment
Dysfunctional Central Venous Access Devices (CVADS)
Drug: Cathflo Activase (Alteplase)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
May 2003
Not Provided

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
Both
up to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00307580
A2404g
Not Provided
Genentech
Genentech
Not Provided
Study Director: Martha Blaney, PharmD Genentech
Genentech
April 2014

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