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NCT03594175 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality
A Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
- Terminated
- Registry status
- Phase 3
- Development phase
- 462
- Enrollment target
NCT03594175: Clinical Trial Phase 3 study, sponsored by Chiesi Farmaceutici S.p.A..
NCT03594175 is a Phase 3 study that was terminated before completion, run by Chiesi Farmaceutici S.p.A.. The registered enrollment target is 462 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594175, a Phase 3 study, was terminated before completion, sponsored by Chiesi Farmaceutici S.p.A..
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 462 participants
- Enrollment target
Study 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.
Primary Outcome
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, mult
Interventions
- DRUG Placebo
- DRUG Alteplase
- DRUG CUSA-081
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 462 participants |
| Start Date | 2020-02-12 |
| Est. Completion | 2023-07-10 |
| Phase | Phase 3 |
Why NCT03594175 stopped before completion
NCT03594175 is an interventional study that assigns participants to a tested intervention. The registered 462 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03594175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03594175 about?
NCT03594175 is a clinical study titled "Efficacy and Safety of CUSA-081 in the Restoration of Central Venous Access Device (CVAD) Functionality". 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.
What is the current status of trial NCT03594175?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 462 participants. The study started on 2020-02-12. Estimated completion is 2023-07-10.
What interventions are being tested in trial NCT03594175?
The interventions under investigation include: Placebo (DRUG), Alteplase (DRUG), CUSA-081 (DRUG).
Who is sponsoring clinical trial NCT03594175?
This trial is sponsored by Chiesi Farmaceutici S.p.A., which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03594175's enrollment target sits among peer trials
462 821st of 2000 higher than 1,179 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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