Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality — READY 1  

Thrombosis Clinical Trial

Official title: A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)

Status Terminated

Clinical Trial Summary

Study to evaluate the efficacy and safety of CUSA-081 in the restoration of central venous access device (CVAD) functionality in participants 18 years and older.

Clinical Trial Description

This is a phase III, multinational, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study to examine CUSA-081 versus placebo or alteplase in subjects with dysfunctional non-hemodialysis Central Venous Access Devices (CVADs).

During the study, the treatment period will consist of one visit which may take place on the same day as screening or on the following day. After meeting all inclusion criteria, subjects will be randomized in a 9:1:6 ratio of CUSA-081: placebo: alteplase. There will be a follow-up assessment performed on Day 30 (±2 days) after treatment with study drug.

Routine blood pressure measurement, heart rate and urine pregnancy test will be performed before enrollment in the study. Safety, including Treatment Emergent AEs (TEAEs), Adverse Drug Reactions (ADRs) and Adverse Events of Special Interest (AESI), will be recorded throughout the study. The end of the trial is defined as the last follow-up contact of the last subject to receive study drug in the trial. ;

Related Conditions & MeSH terms

• Catheter Occlusion
• Thrombosis

• NCT number: NCT03594175
• Study type: Interventional
• Source: Chiesi Farmaceutici S.p.A.
• Status: Terminated
• Phase: Phase 3
• Start date: February 12, 2020
• Completion date: July 10, 2023