Safety, Pharmacokinetics and Efficacy of an AT-III Concentrate.
|ClinicalTrials.gov Identifier: NCT00319228|
Recruitment Status : Active, not recruiting
First Posted : April 27, 2006
Last Update Posted : March 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Antithrombin III Deficiency||Drug: Plasma-derived AT-III concentrate||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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.|
|Actual Study Start Date :||January 2006|
|Estimated Primary Completion Date :||December 2028|
|Estimated Study Completion Date :||March 2029|
|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.
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319228
|Study Director:||Paul J Pinciaro, PhD||Grifols Biologicals Inc.|