NCT03594175

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 462 (actual)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This was a phase III, multinational, multicenter, randomized, double-blind, parallel-group, active and placebo-controlled study to examine CUSA-081 (diluted reteplase) versus placebo or alteplase in subjects with dysfunctional non-hemodialysis Central Venous Access Devices (CVADs). During the study, the treatment period consisted of 1 visit that may have taken place on the same day as screening or on the following day. After complying with all inclusion criteria, subjects were randomized in a 9:1:6 ratio to CUSA-081 : placebo : alteplase treatment group. A follow-up assessment was performed on Day 30 (±2 days) after treatment with study drug. The end of the study was defined as the last follow-up contact of the last subject to receive study drug in the study. Routine blood pressure measurement, heart rate and urine pregnancy test were performed before enrolment in the study. Throughout the study, safety assessment included evaluation of treatment emergent adverse events (TEAEs), adverse drug reactions (ADRs), and adverse events (AE) of Special Interest (AESI). CUSA-081 (reteplase) is a recombinant tissue plasminogen activator (tPA), currently approved in the USA (trade name: RETAVASE®) for treatment of acute ST-elevation myocardial infarction (STEMI) to reduce the risk of death and heart failure. Alteplase, a biosynthetic form of human tPA, Food and Drug Administration (FDA)-approved under the brand name ACTIVASE® for the treatment of acute ischemic stroke, acute myocardial infarction (AMI) to reduce mortality and incidence of heart failure, and acute massive pulmonary embolism for lysis.

Conditions

• Catheter Occlusion
• Thrombosis

Interventions

Type	Name	Description
DRUG	CUSA-081	Participants received 1 or 2 doses of CUSA-081 0.7 mg/2 mL directly into the catheter lumen
DRUG	Placebo	Participants received 1 or 2 doses of placebo (normal saline) directly into the catheter lumen
DRUG	Alteplase	Participants received 1 or 2 doses of alteplase, 2 mg/2 mL, directly into the catheter lumen

Timeline

• Start date: 2020-02-12
• Primary completion: 2023-06-08
• Completion: 2023-07-10
• First posted: 2018-07-20
• Last updated: 2024-08-23
• Results posted: 2024-08-23

Locations

77 sites across 7 countries: United States, Argentina, Belgium, Czechia, Poland, Romania, Spain

Regulatory

• FDA-regulated drug study