A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Access Catheters - Full Text View

Sponsor:	Genentech
Information provided by:	Genentech
ClinicalTrials.gov Identifier:	NCT00396318

Purpose

This is a Phase III, open-label, single-arm study that will be conducted at approximately 35 centers in the United States and Canada. Approximately 210 adult and pediatric subjects with dysfunctional CVA catheters will be enrolled in the study and treated with one or two doses of tenecteplase.

Condition	Intervention	Phase
Dysfunctional Central Venous Access Catheters	Drug: tenecteplase	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	A Phase III, Open-Label, Single-Arm Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Access Catheters

Resource links provided by NLM:

Drug Information available for: Tenecteplase

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

Percentage of subjects who have restoration of CVA catheter function following a single administration of tenecteplase with a dwell time of up to 120 minutes [ Time Frame: 120 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of subjects who have restoration of CVA catheter function following a single administration of tenecteplase [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Percentage of subjects who have restoration of CVA catheter function following a single administration of tenecteplase [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Percentage of subjects who have restoration of CVA catheter function following a second administration of tenecteplase [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
Percentage of subjects who have restoration of CVA catheter function following a second administration of tenecteplase [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]
Percentage of subjects who have restoration of CVA catheter function following administration of one or two doses of tenecteplase [ Time Frame: Length of study ] [ Designated as safety issue: No ]
Percentage of subjects who have restoration of CVA catheter function at any time during the study and who maintain catheter patency the next time the catheter is accessed, up to 7 days following the last dose of tenecteplase [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Enrollment:	253
Study Start Date:	December 2006
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: tenecteplase One or two dose instillation

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinically stable, in the opinion of the investigator
CVA catheter occlusion, defined as inability to withdraw 3 mL of blood for subjects weighing ≥ 10 kg or inability to withdraw 1 mL of blood for subjects weighing < 10 kg
Able to have fluids infused at the volume necessary to instill study drug into the CVA catheter

Exclusion Criteria:

Able to have 3 mL of blood (subjects weighing ≥ 10 kg) or 1 mL of blood (subjects weighing < 10 kg) withdrawn from the selected CVA catheter following subject repositioning
Selected study CVA catheter inserted < 2 days prior to treatment
Selected study CVA catheter implanted specifically for HD
Use of a power injector on the selected study CVA catheter during the study
Evidence of mechanical, non-thrombotic occlusion of the selected study CVA catheter (e.g., kink in the catheter or suture constricting the catheter)
Previously treated in this study or any tenecteplase catheter clearance trial
Use of any investigational drug or therapy within 28 days prior to treatment
Use of a fibrinolytic agent (e.g., alteplase, tenecteplase, reteplase, or urokinase) within 24 hours prior to treatment
Known to be pregnant or breastfeeding at screening
CVA catheter with known or suspected infection
History of any intracranial hemorrhage, aneurysm, or arteriovenous malformation
Use of heparin (unfractionated or low molecular weight) within 24 hours prior to treatment, except for use of intermittent or low-dose, continuous infusion of heparin to maintain catheter or vessel patency
Use of warfarin within 7 days prior to treatment, except for low-dose warfarin used for prophylaxis
Initiation of or increase in dose of Plavix(R) (clopidogrel bisulfate) within 7 days prior to treatment
At high risk for bleeding events or embolic complications (i.e., recent pulmonary embolus, deep vein thrombosis, endarterectomy, or clinically significant right-to-left shunt) in the opinion of the investigator, or with known condition for which bleeding constitutes a significant hazard
Known hypersensitivity to tenecteplase or any component of the formulation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00396318

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Barbara Gillespie, M.D., FASN

Quintiles

More Information

No publications provided

Responsible Party:	Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers:	N3699g
Study First Received:	November 2, 2006
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00396318 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Genentech:

TNKase
CVA
CVAD

Additional relevant MeSH terms:

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

Tenecteplase
Fibrinolytic Agents
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010