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

Phase 3 Completed 100 enrolled Genentech, Inc.

RandomizedParallel-groupDouble-blindTreatment

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).

Timeline

Start: 2006-11
Primary completion: 2008-06
Completion: —

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tenecteplase	Protein / enzyme biologic	2 mg	Other

Indications

No indication recorded.