Efficacy and Safety of Actilyse 2 mg/ 2 ml in Comparison to Saline Solution in Patients With Central Venous Access Device Occlusion

Phase 3

Completed

• Conditions: Catheter Obstruction; Vascular Access Devices
• Interventions: Drug: Actilyse; Drug: Saline solution

• Registration Number: NCT01958164
• Lead Sponsor: Boehringer Ingelheim

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-01
• Study First Submitted QC: 2013-10-08
• Study First Posted: 2013-10-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2015-04
• Results First Submitted: 2015-04-16
• Results First Submitted QC: 2015-04-16
• Last Update Submitted: 2015-04-16
• Results First Posted: 2015-05-01
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline solution (NaCl 0.9%)	Saline solution	Saline solution will be given at time 0. First dose of Actilyse 2mg/2ml will be given to patients if CVAD function has not been restored.
Actilyse 2 mg/2 ml	Actilyse	First dose of Actilyse 2mg/2ml will be given at time 0. Second dose will be given at 120 if CVAD function has not been restored.
Saline solution (NaCl 0.9%)	Actilyse	Saline solution will be given at time 0. First dose of Actilyse 2mg/2ml will be given to patients if CVAD function has not been restored.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Restored CVAD Function at 120 Min After Administration of the First Dose of Study Medication	120 minutes after first drug administration	Proportion (percentage) of patients with restored central venous access device (CVAD) function at 120 min after administration of the first dose of study medication (i.e. Actilyse® or saline solution).

Secondary Outcome Measures

Name	Time	Method
Restored CVAD Function 30 Minutes After Administration of Study Medication at Time 0	30 minutes after first drug administration	Percentage of patients with restored CVAD function 30 minutes after administration of study medication at time 0 (i.e. Actilyse® or saline solution)
Percentage of Participants Who Achieved Restored CVAD Function After 1 Dose and 2 Doses, in Patients From the Actilyse Treatment Group.	0 minutes and 240 minutes	This endpoint was defined as the number of doses required to achieve restored CVAD function in patients from the actilyse treatment group but was analysed as the percentage of participants who achieved restored CVAD function after 1 dose and 2 doses, in patients from the actilyse treatment group.
Restored CVAD Function 30 Minutes After Administration of the Second Dose of Study Medication Actilyse	150 minutes after first drug administration	Percentage of patients with restored CVAD function 30 minutes after administration of the second dose of study medication Actilyse (150 minutes after time 0)
Restored CVAD Function 120 Minutes After Administration of the Second Dose of Study Medication Actilyse	240 minutes after first drug administration	Percentage of patients with restored CVAD function 120 minutes after administration of the second dose of study medication Actilyse (240 minutes after time 0)

Trial Locations

Locations (5)

135.323.3 Boehringer Ingelheim Investigational Site; 🇷🇺 Krasnoyarsk, Russian Federation

135.323.1 Boehringer Ingelheim Investigational Site; 🇷🇺 Akhangelsk, Russian Federation

135.323.2 Boehringer Ingelheim Investigational Site; 🇷🇺 Krasnodar, Russian Federation

135.323.5 Boehringer Ingelheim Investigational Site; 🇷🇺 Samara, Russian Federation

135.323.7 Boehringer Ingelheim Investigational Site; 🇷🇺 St. Petersburg, Russian Federation