drugset / Trial / NCT00056550

Assess Incidence of Deep Vein Thrombosis(DVT)Following Administration of Recombinant Human Antithrombin (rhAT) to Hereditary Antithrombin(AT) Deficient Patients in High Risk Situations.

NCT00056550 ↗

Phase 3 Completed 14 enrolled rEVO Biologics
NaSingle-groupOpen-labelPrevention

Summary

Patients with hereditary antithrombin (AT) deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial is focusing on patients with confirmed hereditary antithrombin deficiency who are undergoing a surgical procedure or induced/spontaneous labor and delivery. The study will test the safety and efficacy of recombinant human antithrombin (rhAT) by infusing rhAT prior to, during and following the period of risk or surgical procedure.

Timeline

Start
2002-12
Primary completion
2004-02
Completion
2004-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant human antithrombin Protein / enzyme biologic — Intravenous