Safety, Pharmacokinetics and Efficacy of an AT-III Concentrate.
|Antithrombin III Deficiency||Drug: Plasma-derived AT-III concentrate||Phase 2 Phase 3|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Prevention
|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.|
- 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 ]
- 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 ]
|Actual Study Start Date:||January 2006|
|Estimated Study Completion Date:||March 2019|
|Estimated Primary Completion Date:||December 2018 (Final data collection date for primary outcome measure)|
|Experimental: Antithrombin III||
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00319228
|Contact: Paul J Pinciaro, PhDemail@example.com|
|United States, New York|
|New York Presbyterian Hospital-Weill Cornell||Not yet recruiting|
|New York, New York, United States, 10021|
|Contact: Jessica Campbell firstname.lastname@example.org|
|United States, Texas|
|University of Texas Health Science Center||Recruiting|
|Houston, Texas, United States, 77030-4009|
|Contact: Kathryn L. Moynihan 713-500-8376 email@example.com|
|Contact: Madeline Cantini 713-500-8377 firstname.lastname@example.org|
|Study Director:||Paul J Pinciaro, PhD||Grifols Biologicals Inc.|