Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

A Phase 2, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety and Activity of Alfimeprase in Patients With Acute Peripheral Arterial Occlusion

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00073554

Enrollment

100

Registered

2003-11-26

Start date

2003-06-30

Completion date

Unknown

Last updated

2009-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Occlusive Diseases, Peripheral Vascular Diseases, Thrombosis

Brief summary

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).

Interventions

DRUGAlfimeprase

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026