Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functio… (NCT03594175) | Clinical Trial Compass
TerminatedPhase 3
Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
Stopped: Due to ongoing recruitment challenges globally, it is not possible to complete this study. The decision is not based on any reported changes in the safety profile or any concerns with the anticipated efficacy profile of the investigational product.
United States462 participantsStarted 2020-02-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Inability to have 3 mL of blood withdrawn from the selected study catheter;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.
Exclusion criteria
✕. 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);
✕
What they're measuring
1
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Min -- CUSA-081 vs Placebo -- Full Analysis Set (FAS)
. 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;