Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices

ARCA Biopharma

Status and phase: Completed; Phase 2

Conditions: Catheters, Indwelling

Treatments: Drug: Alfimeprase

Study type: Interventional

Funder types: Industry

Identifiers

NCT00073515

NuCath-1

HA003

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind