Clinical trial NCT00395876: A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysfunctional Central Venous Access Catheters
Keywords: TNKase
CVA
CVAD
Central venous access catheter
CVA catheter
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2006-11-06
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada. 100 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).


Eligibility criteria: Inclusion Criteria:

* Clinically stable, in the opinion of the investigator
* CVC occlusion
* Able to have fluids infused at the volume necessary to instill study drug into the CVC

Exclusion Criteria:

* Able to have 3 mL of blood (patients weighing ≥ 10 kg) or 1 mL of blood (patients weighing \< 10 kg) withdrawn from the selected study CVC following patient repositioning
* Selected study CVC inserted \< 2 days prior to treatment
* Selected study CVC known to be dysfunctional for \> 7 days
* Selected study CVC implanted specifically for hemodialysis (HD)
* Use of a power injector on the selected study CVC during the study
* Evidence of mechanical, non-thrombotic occlusion of the selected study CVC (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
* CVC 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® (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

Primary outcomes:
measure: Percentage of Patients Who Had Restoration of Central Venous Catheter (CVC) Function Following a Single Administration of Study Drug
timeFrame: 120 minutes after first dose
Secondary outcomes:
measure: Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug
timeFrame: 15 minutes after first dose
measure: Percentage of Patients Who Had Restoration of CVC Function Following a Single Administration of Study Drug
timeFrame: 30 minutes after first dose
measure: Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
timeFrame: 15 minutes after second dose
measure: Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
timeFrame: 30 minutes after second dose
measure: Percentage of Patients Who Had Restoration of CVC Function Following a Second Administration of Study Drug
timeFrame: 120 minutes after second dose
measure: Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
timeFrame: 15 minutes after third dose
measure: Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
timeFrame: 30 minutes after third dose
measure: Percentage of Patients Who Had Restoration of CVC Function Following a Third Administration of Study Drug
timeFrame: 120 minutes after third dose
measure: Percentage of Patients Who Had Restoration of CVC Function Following Administration of One or Two Doses of Tenecteplase
timeFrame: Up to 120 minutes post-treatment
measure: Percentage of Patients Who Had Restoration of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase
timeFrame: Up to 7 days post-treatment
Other outcomes:
Locations:
Study officials:
name: Richard Levine, M.D.
role: STUDY_DIRECTOR
References:
citation: Gabrail N, Sandler E, Charu V, Anas N, Lim E, Blaney M, Ashby M, Gillespie BS, Begelman SM. TROPICS 1: a phase III, randomized, double-blind, placebo-controlled study of tenecteplase for restoration of function in dysfunctional central venous catheters. J Vasc Interv Radiol. 2010 Dec;21(12):1852-8. doi: 10.1016/j.jvir.2010.09.002.