Clinical Trial: Safety, Pharmacokinetics and Efficacy of an AT-III Concentrate.

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Thromboembol

Brief 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 Summary:

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, 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.


Sponsor: Grifols Biologicals Inc.

Current Primary Outcome:

  • The primary objectives of this clinical study are to: [ Time Frame: 2 years ]
  • Assess the pharmacokinetic (PK) profile of AT-III in congenital AT-III deficient patients [ Time Frame: 1 year ]
  • To measure the in vivo recovery and half-life of AT-III. [ Time Frame: 1 year ]
  • To assess the clinical safety and tolerability of AT-III-DAF/DI. [ Time Frame: 1 year ]


Original Primary Outcome:

  • The primary objectives of this clinical study are to:
  • Assess the pharmacokinetic (PK) profile of AT-III in congenital AT-III deficient patients
  • To measure the in vivo recovery and half-life of AT-III.
  • To assess the clinical safety and tolerability of AT-III-DAF/DI.


Current Secondary Outcome: To assess clinical efficacy by preventing thromboembolic or thrombotic events (prophylaxis) in individuals with congenital AT-III deficiency who are undergoing surgical procedures or who are pregnant and undergoing parturition. [ Time Frame: 1 year ]

Original Secondary Outcome: To assess clinical efficacy by preventing thromboembolic or thrombotic events (prophylaxis) in individuals with congenital AT-III deficiency who are undergoing surgical procedures or who are pregnant and undergoing parturition.

Information By: Grifols Biologicals Inc.

Dates:
Date Received: April 26, 2006
Date Started: January 2006
Date Completion: March 2019
Last Updated: January 20, 2017
Last Verified: January 2017