CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 251 enrolled
Drug / intervention
tenecteplasedrug
Likely dose
tenecteplase 2 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00396318
NCT00396318Phase 3Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted Nov 6, 2006·Updated Apr 27, 2011

In Brief

A Phase 3 clinical trial evaluating tenecteplase for Dysfunctional Central Venous Access Catheters. Completed, enrolled 251 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDysfunctional Central Venous Access Catheters
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2006
Enrollment StartDec 1, 2006
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 19.7 years ago

Interventions

tenecteplasedrug

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).