drugset / Trial / NCT00110513

Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery

NCT00110513 ↗

Phase 3 Completed 18 enrolled rEVO Biologics
NaSingle-groupOpen-labelPrevention

Summary

Patients with hereditary antithrombin deficiency are at increased risk of venous thrombosis and pulmonary embolism, particularly during certain high risk procedures. The trial focused on patients with confirmed hereditary antithrombin deficiency who were undergoing a surgical procedure or induced/spontaneous labor and delivery, and/or caesarean section. The study assessed the incidence of thromboembolic events following prophylactic intravenous administration of recombinant human antithrombin (rhAT) to patients with hereditary antithrombin (AT) deficiency in situations usually associated with a high risk for thromboembolic events.

Timeline

Start
2005-04
Primary completion
2008-05
Completion
2008-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant human antithrombin Protein / enzyme biologic — Intravenous