CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 16 enrolled
Drug / intervention
Actilyse +3 moredrug
Likely dose
Actilyse 2mgfrom 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/NCT01958164
NCT01958164Phase 3Completed
CompareCT.gov

A Multicenter, Open-label, Randomised, Clinical Trial to Compare the Efficacy and Safety of Actilyse 2 mg/ 2 ml Versus Saline Solution in Restoring Function of an Occluded Central Venous Access Device

Boehringer Ingelheim·interventional·Posted Oct 9, 2013·Updated May 1, 2015

In Brief

A Phase 3 clinical trial evaluating Actilyse and Saline solution for Catheter Obstruction and Vascular Access Devices. Completed, enrolled 16 participants across 5 sites.

Detailed Summary

This is a multicentre, open-label, randomised, phase III study designed to evaluate the efficacy and safety of Actilyse 2 mg/2 ml in the restoration of function of CVAD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCatheter Obstruction, Vascular Access Devices
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 9, 2013
Enrollment StartSep 1, 2013
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.7 years ago

Interventions

Actilysedrug

Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.

Saline solutiondrug

Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II

Actilysedrug

Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.

Actilysedrug

Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.