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Thrombolytic Agent

CUSA-081 for Blood Clot (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

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 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

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.

Find a Location

Who is running the clinical trial?

Chiesi Farmaceutici S.p.A.Lead Sponsor
201 Previous Clinical Trials
312,437 Total Patients Enrolled
~83 spots leftby Sep 2025
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