Completed
A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion
What is being tested
Data Collection
Who is being recruted
Arterial Occlusive Diseases+6
+ Arteriosclerosis
+ Cardiovascular Diseases
Over 18 Years
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: June 2003
Summary
Principal SponsorARCA Biopharma, Inc.
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2003
Actual date on which the first participant was enrolled.This trial is for patients with acute occlusion of one of the arteries supplying blood to the leg. The trial is designed to determine the safety and activity of a novel clot dissolving (thrombolytic) drug (alfimeprase).
Principal SponsorARCA Biopharma, Inc.
Last updated: January 14, 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
100 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
Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesThrombosisVascular DiseasesPeripheral Vascular DiseasesEmbolism and ThrombosisAtherosclerosisPeripheral Arterial Disease
Criteria
* Patients with acute peripheral arterial occlusion of the lower limb (onset of symptoms within 14 days) * Rutherford Class I or IIa (minimal sensory loss, no muscle weakness, audible venous flow) * Age 18 or above * Able to consent * Able to follow up
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