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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Catheter Occlusion, Thrombosis

In brief

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.

Key facts

Study ID

NCT03594175

Run by

Chiesi Farmaceutici S.p.A.

People needed

462

Starts

2020-02-12

Expected to finish

2023-07-10

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Inability to have 3 mL of blood withdrawn from the selected study catheter;
• A single or multi-lumen CVAD, implanted ports or peripherally inserted central catheters (PICCs) in place for > 24 hours and documented as previously being patent and functional;
• Ability to designate one dysfunctional lumen of a multi-lumen catheter to be used throughout the study for both study drug instillation and assessment of CVAD function;
• Male and non-pregnant female subjects from all racial and ethnic groups 18 years of age and older;
• Able to have fluids infused at the volume necessary to instil study drug into the CVAD (i.e., up to 2 mL);
• Informed consent form (ICF) signed and dated indicating that the subject has been informed of and agreed with all pertinent aspects of the study and is willing to comply with all study requirements and procedures.

You may not qualify if…

• CVAD (any type) used for hemodialysis;
• CVAD known to be dysfunctional for more than 48 hours;
• Reasonable evidence of mechanical or non-thrombotic occlusion in the selected study catheter (e.g., catheter malposition or migration, sutures, kinks, or precipitates causing obstruction), radiographic assessment is not required;
• Known or suspected catheter related bloodstream infection (CRBSI);
• Use of any fibrinolytic agent or anticoagulant (e.g., alteplase, tenecteplase, reteplase, urokinase or heparin) within 24 hours prior to the treatment period (first instillation of study drug). Use of subcutaneous low molecular weight heparin (LMWH) for prophylaxis of thromboembolic events is allowed;
• Known to be at high risk for bleeding events or embolic complications in the opinion of the Investigator, or has a known condition for which bleeding constitutes a significant hazard (e.g. recent stroke, recent intracranial or intraspinal surgery or serious head trauma, intracranial neoplasm, arteriovenous malformation or aneurysm, known bleeding diathesis);
• Uncontrolled hypertension (systolic BP ≥160 or diastolic BP ≥110 mmHg) at screening;
• Clinically unstable in the opinion of the site investigator;
• Known to be pregnant or breastfeeding at screening;
• Previously treated in this study (READY 1) or in study READY 2;
• History of allergic reaction to reteplase, alteplase or vial ingredients (excipients or diluents);
• Use of any investigational drug or experimental medical device within 28 days prior to treatment; non interventional observational studies participation is allowed.
• Not mentally, socially, or otherwise able to complete the trial assessment or not likely to survive beyond 30 days.

Where it is running

• Chiesi Investigational Site — Redlands, California, United States
• Chiesi Investigational Site — Stockton, California, United States
• Chiesi Investigational Site — Norwich, Connecticut, United States
• Chiesi Investigational Site — Newark, Delaware, United States
• Chiesi Investigational Site — Jacksonville, Florida, United States
• Chiesi Investigational Site — Miami, Florida, United States
• Chiesi Investigational Site — Plantation, Florida, United States
• Chiesi Investigational Site — Weeki Wachee, Florida, United States
• Chiesi Investigational Site — Weston, Florida, United States
• Chiesi Investigational Site — Atlanta, Georgia, United States
• Chiesi Investigational Site — Honolulu, Hawaii, United States
• Chiesi Investigational Site — Quincy, Illinois, United States
• Chiesi Investigational Site — New Albany, Indiana, United States
• Einspahr — Topeka, Kansas, United States
• Chiesi Investigational Site — Lewiston, Maine, United States
• Chiesi Investigational Site — Hannibal, Missouri, United States
• Chiesi Investigational Site — Kalispell, Montana, United States
• Chiesi Investigational Site — Omaha, Nebraska, United States
• Chiesi Investigational Site — Howell Township, New Jersey, United States
• Chiesi Investigational Site — New Brunswick, New Jersey, United States
• Chiesi Investigational Site — Durham, North Carolina, United States
• Chiesi Investigational Site — Winston-Salem, North Carolina, United States
• Chiesi Investigational Site — Toledo, Ohio, United States
• Chiesi Investigational Site — Toledo, Ohio, United States
• Chiesi Investigational Site — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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