A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

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).

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 10 kg) withdrawn from the selected study CVC following patient repositioning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