Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate

Antithrombin III Deficiency Clinical Trial

Official title: A Phase II/III Pivotal Trial Evaluating the Safety, Pharmacokinetic Properties and Efficacy of a Plasma-Derived Anti-thrombin III Concentrate With Administration in Surgery, Pregnancy and Thromboembolic or Thrombotic Events

Status Active, not recruiting

Clinical Trial Summary

To assess the safety, pharmacokinetics and efficacy of a plasma-derived AT-III concentrate in the treatment of subjects with congenital AT-III deficiency.

Clinical Trial Description

This study will be a prospective, unblinded, non-randomized, open-label, multi-center Phase II/III study with 2 segments, i.e. a PK evaluation (Segment I), and an assessment of prophylaxis in surgical interventions and pregnancy/delivery, (Segment II). During the PK segment (Segment I), the subjects would remain on their current anticoagulation therapy except for subjects on heparin therapy where a wash-out period of at least 5 half-lives would be required. In total, 15 subjects with congenital ATIII Deficiency will be enrolled for the PK assessment (Segment I).

For Segment II, fifteen episodes will be treated. Recruitment of individual subjects with high risk for venous thrombosis for Segment II of this study is necessary because of the rarity of Antithrombin deficiency in the population. ;

Related Conditions & MeSH terms

• Antithrombin III Deficiency

• NCT number: NCT00319228
• Study type: Interventional
• Source: Grifols Biologicals, LLC
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: January 2006
• Completion date: March 2029