A Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters (TROPICS 2)

Genentech

Status and phase

Completed

Phase 3

Conditions

Dysfunctional Central Venous Access Catheters

Treatments

Drug: tenecteplase

Study type

Interventional

Funder types

Industry

Identifiers

NCT00396318

N3699g

Details and patient eligibility

About

This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study and treated with one or two doses of tenecteplase.

Enrollment

251 patients

Sex

All

Volunteers

No Healthy Volunteers

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 10 kg) withdrawn from the selected CVC following patient repositioning
Selected study CVC inserted < 2 days prior to treatment
Selected study CVC implanted specifically for hemodialysis (HD) or internally coated with any therapeutic agent
Use of a power injector on the selected study CVC during study drug treatment
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
Known bacteremia or known or suspected infection in the CVC catheter
Known history of intracranial hemorrhage (within the previous 3 years), intracranial aneurysm, or arteriovenous malformation
Use of heparin (unfractionated or low molecular weight) or any other anticoagulants within 24 hours prior to treatment, except heparin used for prophylaxis or intermittent or low-dose, continuous infusion of heparin to maintain catheter or vessel patency
Subjects treated with warfarin only: international normalized ratio (INR) ≥ 3.0 within 7 days prior to Visit 1, or a target INR range that allows for an INR ≥ 3.0
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