Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00319228
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-08-25
First Post:
2006-04-26
Brief Title:
Safety Pharmacokinetics and Efficacy of an ATIII Concentrate
Sponsor:
Grifols Biologicals LLC
Organization:
Grifols Biologicals LLC
Study Overview
Official Title:
A Phase IIIII 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
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
This study will be a prospective unblinded non-randomized open-label multi-center Phase IIIII study with 2 segments ie a PK evaluation Segment I and an assessment of prophylaxis in surgical interventions and pregnancydelivery 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None