A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)
Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality (READY 1)
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.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Inability to have 3mL of blood withdrawn from the selected study catheter;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 instill 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.
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- 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 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.
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Chiesi Farmaceutici S.p.A.