Alfimeprase for Thrombolysis in Acute Peripheral Arterial Occlusion

ARCA Biopharma

Status and phase: Completed; Phase 2

Conditions: Peripheral Vascular Diseases; Thrombosis; Arterial Occlusive Diseases

Treatments: Drug: Alfimeprase

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00073554

HA002

NAPA-1

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)