- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03594175
Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality (READY 1)
A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Chiesi Clinical Trial Information
- Phone Number: +39 0521 279 715
- Email: clinicaltrials_info@chiesi.com
Study Locations
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Cordoba, Argentina, 5000
- Chiesi Investigational Site
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Cordoba, Argentina, X5000JHQ
- Chiesi Investigational Site
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Cordoba, Argentina, X5002AOQ
- Chiesi Investigational Site
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Cordoba, Argentina, X5021FPQ
- Chiesi Investigational Site
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Salta, Argentina, A4400ANW
- Chiesi Investigational Site
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Salta, Argentina, A4400
- Chiesi Investigational Site
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San Juan, Argentina, 5400
- Chiesi Investigational Site
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Buenos Aires
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Mar del Plata, Buenos Aires, Argentina, B7600FYK
- Chiesi Investigational Site
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Cordoba
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Villa Maria, Cordoba, Argentina, X5900JKA
- Chiesi Investigational Site
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Santa Fe
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Rosario, Santa Fe, Argentina, S2000DIF
- Chiesi Investigational Site
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Arlon, Belgium, 6700
- Chiesi Investigational Site
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Bonheiden, Belgium, 2820
- Chiesi Investigational Site
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Brugge, Belgium, 8000
- Chiesi Investigational Site
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Gent, Belgium, 9000
- Chiesi Investigational Site
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Hasselt, Belgium, 3500
- Chiesi Investigational Site
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Kortrijk, Belgium, 8500
- Chiesi Investigational Site
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Mechelen, Belgium, 2800
- Chiesi Investigational Site
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Roeselare, Belgium, 8800
- Chiesi Investigational Site
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Brno, Czechia, 625 00
- Chiesi Investigational Site
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Brno, Czechia, 656 91
- Chiesi Investigational Site
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Plzen, Czechia, 305 99
- Chiesi Investigational Site
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Praha 10, Czechia, 10034
- Chiesi Investigational Site
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Praha 2, Czechia, 128 08
- Chiesi Investigational Site
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Praha 5, Czechia, 150 06
- Chiesi Investigational Site
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Slany, Czechia, 274 01
- Chiesi Investigational Site
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Gdansk, Poland, 80-803
- Chiesi Investigational Site
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Katowice, Poland, 40-027
- Chiesi Investigational Site
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Poznan, Poland, 61-866
- Chiesi Investigational Site
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Skawina, Poland, 32-050
- Chiesi Investigational Site
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Tomaszow Mazowiecki, Poland, 97-200
- Chiesi Investigational Site
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Wegrow, Poland, 07-100
- Chiesi Investigational Site
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Bucuresti, Romania, 021659
- Chiesi Investigational Site
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Bucuresti, Romania, 022328
- Chiesi Investigational Site
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Cluj-Napoca, Romania, 400006
- Chiesi Invesitgational Site
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Constanta, Romania, 900591
- Chiesi Investigational Site
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Craiova, Romania, 200347
- Chiesi Investigational Site
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Craiova, Romania, 200640
- Chiesi Investigational Site
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Targu Mures, Romania, 40103
- Chiesi Investigational Site
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Barcelona, Spain, 08041
- Chiesi Investigational Site
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Barcelona, Spain, 8035
- Chiesi Investigational Site
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Sevilla, Spain, 41009
- Chiesi Investigational Site
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Barcelona
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Terrassa, Barcelona, Spain, 08221
- Chiesi Investigational Site
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Arkansas
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Little Rock, Arkansas, United States, 72205
- Chiesi Investigational Site
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California
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Redlands, California, United States, 92373
- Chiesi Investigational Site
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Stockton, California, United States, 95204
- Chiesi Investigational Site
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Connecticut
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Norwich, Connecticut, United States, 06360
- Chiesi Investigational Site
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Delaware
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Newark, Delaware, United States, 19718
- Chiesi Investigational Site
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Florida
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Jacksonville, Florida, United States, 32209
- Chiesi Investigational Site
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Miami, Florida, United States, 33155-3009
- Chiesi Investigational Site
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Plantation, Florida, United States, 33322
- Chiesi Investigational Site
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Weeki Wachee, Florida, United States, 34607
- Chiesi Investigational Site
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Weston, Florida, United States, 33331
- Chiesi Investigational Site
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Georgia
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Atlanta, Georgia, United States, 30322
- Chiesi Investigational Site
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Hawaii
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Honolulu, Hawaii, United States, 96814
- Chiesi Investigational Site
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Illinois
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Quincy, Illinois, United States, 62301
- Chiesi Investigational Site
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Indiana
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New Albany, Indiana, United States, 47150
- Chiesi Investigational Site
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Kansas
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Topeka, Kansas, United States, 66606
- Einspahr
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Maine
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Lewiston, Maine, United States, 04240
- Chiesi Investigational Site
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Missouri
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Hannibal, Missouri, United States, 63401
- Chiesi Investigational Site
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Montana
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Kalispell, Montana, United States, 59901-3158
- Chiesi Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68131
- Chiesi Investigational Site
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New Jersey
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Howell, New Jersey, United States, 07731
- Chiesi Investigational Site
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New Brunswick, New Jersey, United States, 08901
- Chiesi Investigational Site
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North Carolina
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Durham, North Carolina, United States, 27710
- Chiesi Investigational Site
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Winston-Salem, North Carolina, United States, 27103
- Chiesi Investigational Site
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Ohio
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Toledo, Ohio, United States, 43608
- Chiesi Investigational Site
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Toledo, Ohio, United States, 43614
- Chiesi Investigational Site
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104
- Chiesi Investigational Site
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Oregon
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Bend, Oregon, United States, 97701
- Chiesi Investigational Site
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Portland, Oregon, United States, 97210
- Chiesi Investigational Site
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Pennsylvania
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Bethlehem, Pennsylvania, United States, 18015
- Chiesi Investigational Site
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South Carolina
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Charleston, South Carolina, United States, 29414
- Chiesi Investigational Site
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Spartanburg, South Carolina, United States, 29303
- Chiesi Investigational Site
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Tennessee
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Franklin, Tennessee, United States, 37067
- Chiesi Investigational Site
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Knoxville, Tennessee, United States, 37920
- Chiesi Investigational Site
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Virginia
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Fredericksburg, Virginia, United States, 22401
- Chiesi Investigational Site
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Lynchburg, Virginia, United States, 24501
- Chiesi Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
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);
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: CUSA-081
Participants will receive 1 or 2 doses of CUSA-081, 0.7 milligrams (mg) (0.4 units) per 2 milliliter (mL) directly into the catheter lumen.
Participants will receive the first dose at minute (min) 0, and the second dose, if needed, at min 90.
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Participants will receive 1 or 2 doses of CUSA-081 0.7 mg/2 mL directly into the catheter lumen
Other Names:
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Placebo Comparator: Placebo
Participants will receive 1 or 2 doses of placebo (normal saline) directly into the catheter lumen.
Participants will receive the first dose at min 0, and the second dose, if needed, at min 90.
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Participants will receive 1 or 2 doses of placebo (normal saline) directly into the catheter lumen
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Active Comparator: Alteplase
Participants will receive 1 or 2 doses of alteplase, 2 mg/mL, directly into the catheter lumen.
Participants will receive the first dose at min 0, and the second dose, if needed, at min 90.
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Participants will receive 1 or 2 doses of alteplase, 2 mg/2 mL, directly into the catheter lumen
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Mins
Time Frame: Day 1 (up to 90 mins postdose)
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Treatment success is defined as the restoration of CVAD functionality, measured as the ability to withdraw 3 mL of blood and infuse 5 mL of saline.
For this assessment, dwell time is up to 90 mins.
The percentage will be calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
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Day 1 (up to 90 mins postdose)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Total Dwell Time Up To 30 And 60 Mins
Time Frame: Day 1 (up to 30 and 60 mins postdose)
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Treatment success is defined as the restoration of CVAD functionality, measured as the ability to withdraw 3 mL of blood and infuse 5 mL of saline.
For this assessment, dwell time is up to 60 mins.
The percentage will be calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
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Day 1 (up to 30 and 60 mins postdose)
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Percentage Of Participants With Treatment Success After Up To 2 Instillations Of Study Drug With A Total Dwell Time Up To 120, 150, And 180 Mins
Time Frame: Day 1 (up to 120, 150, and 180 mins postdose)
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Treatment success is defined as the restoration of CVAD functionality, measured as the ability to withdraw 3 mL of blood and infuse 5 mL of saline.
For this assessment, dwell time is up to 180 mins.
The percentage will be calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
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Day 1 (up to 120, 150, and 180 mins postdose)
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Rate Of Recurrent Catheter Dysfunction Within 30 Days Following Treatment With Study Drug
Time Frame: Day 1 (postdose) up to Day 30
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The rate of recurrent catheter dysfunction is defined as re-occlusion.
The rate of recurrent catheter dysfunction will be analyzed using the Kaplan-Meier method.
This analysis is based on all participants with treatment success following up to 2 administrations of study drug with a total dwell time up to 180 mins.
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Day 1 (postdose) up to Day 30
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUSA-081-HEM-01
- 2019-002124-32 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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