NCT00319228

Safety, Pharmacokinetics and Efficacy of an ATIII Concentrate

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Grifols Biologicals, LLC · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Antithrombin III Deficiency

Interventions

Type	Name	Description
DRUG	Plasma-derived AT-III concentrate	Segment I: A single dose IV infusion of 50 IU/kg of ATIII-DAF/DI will be administered to each patient. Segment II: A single dose or multiple doses depending on the subject's ATIII plasma levels and patient's specific treatment plan.

Timeline

• Start date: 2006-01-01
• Primary completion: 2028-12-01
• Completion: 2029-03-01
• First posted: 2006-04-27
• Last updated: 2023-08-25