NCT00396318

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

A Phase III, Open-Label, Single-Arm Study of Tenecteplase for Restoration of Function in Dysfunctional Central Venous Catheters

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Dysfunctional Central Venous Access Catheters

Interventions

Type	Name	Description
DRUG	tenecteplase	2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing \< 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-06-01
• First posted: 2006-11-06
• Last updated: 2011-04-27
• Results posted: 2011-04-27