Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery

PHASE3CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

May 31, 2008

Study Completion Date

July 31, 2008

Conditions
Antithrombin III Deficiency
Interventions
BIOLOGICAL

Recombinant human antithrombin (rhAT)

Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient will receive an initial intravenous loading dose followed by a continuous intravenous infusion of recombinant human antithrombin (rhAT) that will target and maintain an AT activity that is \> 80% and \< 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at \> 80% and \< 120% of normal during the high-risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.

Trial Locations (17)

Unknown

New Haven

St Louis

New York

North Gosford

Vienna

Ottawa

Vancouver

Montpellier

Berlin

Alessandria

Exeter

Chichester

Cambridge

Glasgow

London

Nottingham

Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

rEVO Biologics

INDUSTRY

NCT00110513 - Recombinant Human Antithrombin (rhAT) in Patients With Hereditary Antithrombin Deficiency Undergoing Surgery or Delivery | Biotech Hunter | Biotech Hunter