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

NCT03594175 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 462

Last updated 2024-08-23

Study results available
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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.

Conditions

Interventions

DRUG

CUSA-081

Participants received 1 or 2 doses of CUSA-081 0.7 mg/2 mL directly into the catheter lumen

DRUG

Placebo

Participants received 1 or 2 doses of placebo (normal saline) directly into the catheter lumen

DRUG

Alteplase

Participants received 1 or 2 doses of alteplase, 2 mg/2 mL, directly into the catheter lumen

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-12
Primary Completion
2023-06-08
Completion
2023-07-10
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Belgium
  • Czechia
  • Poland
  • Romania
  • Spain

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03594175 on ClinicalTrials.gov