Restoration of Function to CVADsPhase 3READY 2NCT03992443
Efficacy and Safety of CUSA-081 in the Restoration of Dysfunctional Central Venous Access Device (CVAD) Functionality
A Phase 3 study testing CUSA-081 in people with Restoration of Function to CVADs, run by Chiesi Farmaceutici S.p.A. at 15 sites in 3 countries.
Trial summary
Study to evaluate the efficacy and safety of CUSA-081 in the restoration of central venous access device (CVAD) functionality in participants 12 years and older. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Restoration of Function to CVADs
- What is being tested?
- CUSA-081
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 15 sitesin 3 countries
- Study dates
- 28 Feb 2022to 18 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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- Inability to have 3 mL of blood withdrawn from the selected study catheter;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 at least 18 years or older (see note below);
- 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.
- NOTE: A urine pregnancy test is required for all females of childbearing potential. Women in natural post-menopause or permanently sterile do not need to be tested for pregnancy. Natural menopause is defined as the permanent cessation of menstrual periods, determined retrospectively after a woman has experienced 12 consecutive months of lack of menstruation (amenorrhea) without any other obvious pathological or physiological cause. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
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 intravenously administered 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), unfractionated heparin (UFH) or heparinoids for prophylaxis of thromboembolic events is allowed. Furthermore, the use of oral anticoagulants 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 2) or in study READY 1;
- History of allergic reaction to reteplase or vial ingredients (excipients or diluents);
- Use of any investigational drug or experimental medical device within 28 days prior to treatment; non interventional observational study participation is allowed;
- Not mentally, socially or otherwise able to complete the trial assessments or not likely to survive beyond 30 days.
Trial locations and contacts
15 sites in 3 countries.
15 sites in 3 countries
United States7 sites
Chiesi Investigational site
Dayton, Ohio, 45390
Chiesi investigation site
Greenville, North Carolina, 80015
Chiesi Investigational site
Huntersville, North Carolina, 28070
Chiesi investigational site
Ohio City, Ohio, 44701
Chiesi investigational site
San Luis Obispo, California, 93401
Chiesi Investigational site
Tampa, Florida, 33601
Chiesi Investigational site
Torrance, California, 90501
Bulgaria5 sites
Chiesi investigational site
Pleven
Chiesi Investigational site
Plovdiv
Chiesi Investigational Site
Razgrad
Chiesi Investigational site
Sofia
Chiesi Investigational site
Stara Zagora
Hungary3 sites
Chiesi investigational site
Budapest
Chiesi investigational site
Kecskemét
Chiesi investigational site
Székesfehérvár
About this study
Official title: A Phase 3, Open Label, Single Arm Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)
Study to evaluate the efficacy and safety of CUSA-081 in the restoration of central venous access device (CVAD) functionality in participants 12 years and older.
- Conditions
- Restoration of Function to CVADs
- Being tested
- CUSA-081
- Keywords
- CVAD, CUSA-081, reteplase
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, 0.70 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, 0.70 milligrams (mg) 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. Assessments were performed at min 30, 60, 90, 120, 150, and 180. Receives: Drug: CUSA-081 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)
TEAEs were defined as any adverse event (AE) with a start date on or after administration of the study drug (on Day 1). A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 through the Follow-up Visit (Day 30) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Measured: Day 1 (postdose) through Day 30
Secondary outcomes (2)
Percentage Of Participants Who Had Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Minutes
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 was up to 90 minutes. The percentage was calculated as the number of participants who had treatment success divided by the total number of participants in the group, multiplied by 100%.
Measured: Day 1 (up to 90 mins postdose)
Rate Of Recurrent Catheter Dysfunction Within 30 Days Following Treatment With Study Drug
The rate of recurrent catheter dysfunction is defined as re-occlusion.
Measured: Day 1 (postdose) up to Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start28 Feb 2022
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Why it stopped: Chiesi business decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restoration of Function to CVADsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT03992443
- Sponsor's protocol ID
- CUSA-081-HEM-02
- Other IDs
- 2021-004026-30
- Acronym
- READY 2
- Status last verified
- Apr 2022
- First submitted
- 18 Jun 2019
- Last updated
- 15 Apr 2022
- Results posted
- No
- 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 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Open Label, Single Arm Study on the Use of CUSA-081 for Dysfunctional Central Venous Access Devices (CVADs)
- ClinicalTrials.gov ID
- NCT03992443
- Acronym / sponsor ID
- READY 2 / CUSA-081-HEM-02
- Conditions
- Restoration of Function to CVADs
- Keywords
- CVAD, CUSA-081, reteplase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Chiesi business decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to evaluate the efficacy and safety of CUSA-081 in the restoration of central venous access device (CVAD) functionality in participants 12 years and older.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CUSA-081 | Experimental | Drug: CUSA-081Participants received 1 or 2 doses of CUSA-081, 0.70 milligrams (mg) 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. Assessments were performed at min 30, 60, 90, 120, 150, and 180. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 at least 18 years or older (see note below);
- Able to have fluids infused at the volume necessary to instill 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 intravenously administered 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), unfractionated heparin (UFH) or heparinoids for prophylaxis of thromboembolic events is allowed. Furthermore, the use of oral anticoagulants 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, 0.70 mg/2 mL, directly into the catheter lumen | Drug | CUSA-081 |
Primary outcome
Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 (postdose) through Day 30
TEAEs were defined as any adverse event (AE) with a start date on or after administration of the study drug (on Day 1). A severe AE was defined as an AE that was incapacitating and required medical intervention. The number of participants who experienced 1 or more severe TEAEs after dosing on Day 1 through the Follow-up Visit (Day 30) is presented. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
2 secondary outcomes
Percentage Of Participants Who Had Treatment Success Following A Single Instillation Of Study Drug With A Dwell Time Up To 90 Minutes
Time frame: Day 1 (up to 90 mins postdose)
Rate Of Recurrent Catheter Dysfunction Within 30 Days Following Treatment With Study Drug
Time frame: Day 1 (postdose) up to Day 30
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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.
15 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CUSA-081 in people with Restoration of Function to CVADs, run by Chiesi Farmaceutici S.p.A. at 15 sites in 3 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 7 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: withdrawn, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Bulgaria, Hungary. 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number Of Participants Who Experienced Severe Treatment-emergent Adverse Events (TEAEs) (time frame: Day 1 (postdose) through Day 30). 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 15 Apr 2022.