Completed
A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters
What is being tested
Data Collection
Who is being recruted
Cardiovascular Diseases+1
+ Thrombosis
+ Vascular Diseases
Over 18 Years
How is the trial designed
Treatment Study
Phase 2
Interventional
Summary
Principal SponsorARCA Biopharma, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment.
Official TitleA Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters
Principal SponsorARCA Biopharma, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
115 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Cardiovascular DiseasesThrombosisVascular DiseasesEmbolism and Thrombosis
Criteria
Subjects must: * have a dysfunctional Central Venous Access Device (CVAD) defined as unable to withdraw 3 mL blood * have had the device in place for \> 48 hours * be clinically stable * be 18 or older * give informed consent
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center