Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality (READY1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Chiesi Farmaceutici S.p.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (up to 180 min post dose)

Awards & highlights

Pivotal Trial

Summary

This trial tests CUSA-081 to see if it can fix medical devices used for accessing veins in adults. The goal is to restore the function of these devices by clearing issues.

Eligible Conditions

Blood Clot
Catheter Blockage

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (up to 180 min post dose)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (up to 180 min post dose)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (up to 180 min post dose) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Secondary study objectives

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)

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)

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)

+4 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: CUSA-081Experimental Treatment1 Intervention

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.

Group II: AlteplaseActive Control1 Intervention

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.

Group III: PlaceboPlacebo Group1 Intervention

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.

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