Catheter OcclusionPhase 3READY1NCT03594175
Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
A Phase 3 study testing CUSA-081 and Alteplase in people with Catheter Occlusion and Thrombosis, run by Chiesi Farmaceutici S.p.A. at 77 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Catheter Occlusion, Thrombosis
- What is being tested?
- CUSA-081 and Alteplase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 462 participants
- Where
- 77 sitesin 7 countries
- Study dates
- 12 Feb 2020to 10 Jul 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inability to have 3 mL of blood withdrawn from the selected study catheter;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.
Who cannot join
- 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);
Show all 13Show fewer
- 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.
Trial locations and contacts
77 sites in 7 countries.
77 sites in 7 countries
United States35 sites
Chiesi Investigational Site
Atlanta, Georgia, 30322
Chiesi Investigational Site
Bend, Oregon, 97701
Chiesi Investigational Site
Bethlehem, Pennsylvania, 18015
Chiesi Investigational Site
Charleston, South Carolina, 29414
Chiesi Investigational Site
Durham, North Carolina, 27710
Chiesi Investigational Site
Franklin, Tennessee, 37067
Chiesi Investigational Site
Fredericksburg, Virginia, 22401
Chiesi Investigational Site
Hannibal, Missouri, 63401
Chiesi Investigational Site
Honolulu, Hawaii, 96814
Chiesi Investigational Site
Howell Township, New Jersey, 07731
Chiesi Investigational Site
Jacksonville, Florida, 32209
Chiesi Investigational Site
Kalispell, Montana, 59901-3158
Chiesi Investigational Site
Knoxville, Tennessee, 37920
Chiesi Investigational Site
Lewiston, Maine, 04240
Chiesi Investigational Site
Little Rock, Arkansas, 72205
Chiesi Investigational Site
Lynchburg, Virginia, 24501
Chiesi Investigational Site
Miami, Florida, 33155-3009
Chiesi Investigational Site
New Albany, Indiana, 47150
Chiesi Investigational Site
New Brunswick, New Jersey, 08901
Chiesi Investigational Site
Newark, Delaware, 19718
Chiesi Investigational Site
Norwich, Connecticut, 06360
Chiesi Investigational Site
Oklahoma City, Oklahoma, 73104
Chiesi Investigational Site
Omaha, Nebraska, 68131
Chiesi Investigational Site
Plantation, Florida, 33322
Chiesi Investigational Site
Portland, Oregon, 97210
Chiesi Investigational Site
Quincy, Illinois, 62301
Chiesi Investigational Site
Redlands, California, 92373
Chiesi Investigational Site
Spartanburg, South Carolina, 29303
Chiesi Investigational Site
Stockton, California, 95204
Chiesi Investigational Site
Toledo, Ohio, 43608
Chiesi Investigational Site
Toledo, Ohio, 43614
Einspahr
Topeka, Kansas, 66606
Chiesi Investigational Site
Weeki Wachee, Florida, 34607
Chiesi Investigational Site
Weston, Florida, 33331
Chiesi Investigational Site
Winston-Salem, North Carolina, 27103
Argentina10 sites
Chiesi Investigational Site
Córdoba, 5000
Chiesi Investigational Site
Córdoba, X5000JHQ
Chiesi Investigational Site
Córdoba, X5002AOQ
Chiesi Investigational Site
Córdoba, X5021FPQ
Chiesi Investigational Site
Mar del Plata, Buenos Aires, B7600FYK
Chiesi Investigational Site
Rosario, Santa Fe Province, S2000DIF
Chiesi Investigational Site
Salta, A4400ANW
Chiesi Investigational Site
Salta, A4400
Chiesi Investigational Site
San Juan, 5400
Chiesi Investigational Site
Villa María, Córdoba Province, X5900JKA
Belgium8 sites
Chiesi Investigational Site
Arlon, 6700
Chiesi Investigational Site
Bonheiden, 2820
Chiesi Investigational Site
Bruges, 8000
Chiesi Investigational Site
Ghent, 9000
Chiesi Investigational Site
Hasselt, 3500
Chiesi Investigational Site
Kortrijk, 8500
Chiesi Investigational Site
Mechelen, 2800
Chiesi Investigational Site
Roeselare, 8800
Czechia7 sites
Chiesi Investigational Site
Brno, 625 00
Chiesi Investigational Site
Brno, 656 91
Chiesi Investigational Site
Pilsen, 305 99
Chiesi Investigational Site
Prague, 10034
Chiesi Investigational Site
Prague, 128 08
Chiesi Investigational Site
Prague, 150 06
Chiesi Investigational Site
Slaný, 274 01
Romania7 sites
Chiesi Investigational Site
Bucharest, 021659
Chiesi Investigational Site
Bucharest, 022328
Chiesi Invesitgational Site
Cluj-Napoca, 400006
Chiesi Investigational Site
Constanța, 900591
Chiesi Investigational Site
Craiova, 200347
Chiesi Investigational Site
Craiova, 200640
Chiesi Investigational Site
Târgu Mureş, 40103
Poland6 sites
Chiesi Investigational Site
Gdansk, 80-803
Chiesi Investigational Site
Katowice, 40-027
Chiesi Investigational Site
Poznan, 61-866
Chiesi Investigational Site
Skawina, 32-050
Chiesi Investigational Site
Tomaszów Mazowiecki, 97-200
Chiesi Investigational Site
Węgrów, 07-100
Spain4 sites
Chiesi Investigational Site
Barcelona, 08041
Chiesi Investigational Site
Barcelona, 8035
Chiesi Investigational Site
Seville, 41009
Chiesi Investigational Site
Terrassa, Barcelona, 08221
About this study
Official title: A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)
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.
Read the 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
- Being tested
- CUSA-081, Placebo, Alteplase
- Keywords
- Central Venous Access Device (CVAD), CUSA-081, reteplase, alteplase, occluded catheters, catheter, occlusion, thrombosis, thrombotic occlusion, CVAD
- Medical subject headings
- Thrombosis, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CUSA-081Drug
Also called Reteplase
Participants received 1 or 2 doses of CUSA-081 0.7 mg/2 mL directly into the catheter lumen
PlaceboDrug
Participants received 1 or 2 doses of placebo (normal saline) directly into the catheter lumen
AlteplaseDrug
Participants received 1 or 2 doses of alteplase, 2 mg/2 mL, directly into the catheter lumen
| Study group | Role | What they receive |
|---|---|---|
| CUSA-081 | Experimental | Participants received 1 or 2 doses of CUSA-081, 0.7 milligrams (mg) (0.4 units) per 2 milliliter (mL) directly into the catheter lumen. Participants received the first dose at minute (min) 0, and the second dose (if needed) at min 90. Receives: Drug: CUSA-081 |
| Placebo | Placebo comparator | Participants received 1 or 2 doses of placebo (normal saline) directly into the catheter lumen. Participants received the first dose at min 0, and the second dose (if needed) at min 90. Receives: Drug: Placebo |
| Alteplase | Active comparator | Participants received 1 or 2 doses of alteplase, 2 mg/mL, directly into the catheter lumen. Participants received the first dose at min 0, and the second dose (if needed) at min 90. Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
CUSA-081 vs Placebo -- Single instillation of study drug -- Dwell Time Up To 90 Min -- Full Analysis Set (FAS)
Treatment success was 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 was up to 90 mins, after a single instillation of study drug. The percentage was calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
Measured: Day 1 (up to 90 mins post dose)
Secondary outcomes (7)
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Min -- CUSA-081 vs Alteplase -- Per Protocol Set (PP)
CUSA-081 vs Alteplase -- Single instillation of study drug -- Dwell Time Up To 90 Min -- Per Protocol set (PP)
Treatment success was 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 was up to 90 mins, after a single instillation of study drug. The percentage was calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
The PP set was used for sensitivity analysis when testing for non-inferiority.
Measured: Day 1 (up to 90 min post dose)
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 60 Min -- CUSA-081 vs Placebo -- Full Analysis Set (FAS)
CUSA-081 vs Placebo -- Single instillation of study drug -- Dwell Time Up To 60 Min -- Full Analysis set (FAS)
Treatment success was 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 was up to 60 mins, after a single instillation of study drug.
The percentage was calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
Measured: Day 1 (up to 60 min post dose)
Percentage Of Participants With Treatment Success Following 2 Instillations Of Study Drug With A Dwell Time Up To 180 Min -- CUSA-081 vs Placebo -- Full Analysis Set (FAS)
CUSA-081 vs Placebo -- 2 Instillations of study drug -- Dwell Time Up To 180 Min -- Full Analysis set (FAS)
Treatment success was 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 was up to 180 mins, following 2 installations of the study drug. The percentage was calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
Subjects received the first instillation of study drug (CUSA-081, placebo, or alteplase). If patency was not restored after 90 minutes following the first instillation, a second dose of study drug (the same drug as at first instillation) was administered.
Measured: Day 1 (up to 180 min post dose)
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Min -- CUSA-081 vs Alteplase -- Full Analysis Set (FAS)
CUSA-081 vs Alteplase -- Single instillation of study drug -- Dwell Time Up To 90 Min -- Full Analysis set (FAS)
Treatment success was 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, after a single instillation of study drug. The percentage was calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
Measured: Day 1 (up to 90 min post dose)
Rate Of Recurrent Catheter Dysfunction Within 30 Days Following Treatment With Study Drug
The rate of recurrent catheter dysfunction is defined as re-occlusion. The rate of recurrent catheter dysfunction within 30 days following treatment and the results of the Kaplan-Meier and Cox proportional hazards analyses of the time to first re-occlusion are presented in the FAS.
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 min.
Subjects received the first instillation of study drug (CUSA-081, placebo, or alteplase). If patency was not restored after 90 minutes following the first instillation, a second dose of study drug (the same drug as at first instillation) was administered.
Measured: Day 1 (post dose) up to Day 30
Percentage of Participants With Treatment-emergent Adverse Events (AEs) Leading to Study Discontinuation
Treatment-emergent AEs leading to study discontinuation were evaluated and the percentage of participants with at least one event reported.
For all subjects who discontinued the study, the AE was 'Device breakage'.
Measured: Day 1 (start of treatment) and until the end of the treatment period (up to 180 min post dose).
Percentage of Participants With Treatment-emergent Adverse Events (AEs) of Special Interest (AESI)
Treatment-emergent AEs of special interest (AESI) were monitored. These included major bleeding (defined as severe blood loss [>5 mL/kg] or blood loss requiring transfusion or causing hypotension requiring use of inotropic agents), embolism, thrombosis, and catheter-related blood stream infection. An adverse event was considered as treatment-emergent if it started on or after the first dose of study drug intake up to the end of the 180-minute treatment period.
Measured: Day 1 (start of treatment) and until the end of the treatment period (up to 180 min post dose).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start12 Feb 2020
- Primary completion8 Jun 2023
- Study completion10 Jul 2023
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Catheter OcclusionStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03594175
- Sponsor's protocol ID
- CUSA-081-HEM-01
- Other IDs
- 2019-002124-32, 2019
- Acronym
- READY1
- Status last verified
- Aug 2024
- First submitted
- 10 Jul 2018
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Double-Blind, Active and Placebo-Controlled Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)
- ClinicalTrials.gov ID
- NCT03594175
- Acronym / sponsor ID
- READY1 / CUSA-081-HEM-01
- Conditions
- Catheter Occlusion, Thrombosis
- Keywords
- Central Venous Access Device (CVAD), CUSA-081, reteplase, alteplase, occluded catheters, catheter, occlusion, thrombosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 462 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 10 Jul 2023 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CUSA-081 | Experimental | Drug: CUSA-081Participants received 1 or 2 doses of CUSA-081, 0.7 milligrams (mg) (0.4 units) per 2 milliliter (mL) directly into the catheter lumen. Participants received the first dose at minute (min) 0, and the second dose (if needed) at min 90. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received 1 or 2 doses of placebo (normal saline) directly into the catheter lumen. Participants received the first dose at min 0, and the second dose (if needed) at min 90. |
| Alteplase | Active comparator | Drug: AlteplaseParticipants received 1 or 2 doses of alteplase, 2 mg/mL, directly into the catheter lumen. Participants received the first dose at min 0, and the second dose (if needed) at min 90. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CUSA-081Also: ReteplaseParticipants received 1 or 2 doses of CUSA-081 0.7 mg/2 mL directly into the catheter lumen | Drug | CUSA-081 |
| PlaceboParticipants received 1 or 2 doses of placebo (normal saline) directly into the catheter lumen | Drug | Placebo |
| AlteplaseParticipants received 1 or 2 doses of alteplase, 2 mg/2 mL, directly into the catheter lumen | Drug | Alteplase |
Primary outcome
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)
Time frame: Day 1 (up to 90 mins post dose)
CUSA-081 vs Placebo -- Single instillation of study drug -- Dwell Time Up To 90 Min -- Full Analysis Set (FAS) Treatment success was 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 was up to 90 mins, after a single instillation of study drug. The percentage was calculated as the number of participants with treatment success divided by the total number of participants in the group, multiplied by 100%.
7 secondary outcomes
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Min -- CUSA-081 vs Alteplase -- Per Protocol Set (PP)
Time frame: Day 1 (up to 90 min post dose)
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 60 Min -- CUSA-081 vs Placebo -- Full Analysis Set (FAS)
Time frame: Day 1 (up to 60 min post dose)
Percentage Of Participants With Treatment Success Following 2 Instillations Of Study Drug With A Dwell Time Up To 180 Min -- CUSA-081 vs Placebo -- Full Analysis Set (FAS)
Time frame: Day 1 (up to 180 min post dose)
Percentage Of Participants With Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Min -- CUSA-081 vs Alteplase -- Full Analysis Set (FAS)
Time frame: Day 1 (up to 90 min post dose)
Rate Of Recurrent Catheter Dysfunction Within 30 Days Following Treatment With Study Drug
Time frame: Day 1 (post dose) up to Day 30
Percentage of Participants With Treatment-emergent Adverse Events (AEs) Leading to Study Discontinuation
Time frame: Day 1 (start of treatment) and until the end of the treatment period (up to 180 min post dose).
Percentage of Participants With Treatment-emergent Adverse Events (AEs) of Special Interest (AESI)
Time frame: Day 1 (start of treatment) and until the end of the treatment period (up to 180 min post dose).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
77 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CUSA-081 and Alteplase in people with Catheter Occlusion and Thrombosis, run by Chiesi Farmaceutici S.p.A. at 77 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in United States, Argentina, Belgium, Czechia, Romania and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Day 1 (up to 90 mins post dose)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.