A multicentre, prospective, open-label, uncontrolled Phase 3 study to assess the efficacy, safety and pharmacokinetics of Atenativ in patients with congenital antithrombin deficiency undergoing surgery or delivery

Conditions

Congenital antithrombin deficiency

Brief summary

Incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition to 30 days post treatment initiation.

Detailed description

• PK parameters: o Area under the curve (AUCnorm(0–∞)) o Maximum plasma concentration (Cmax) o Half-life (t1/2) o Mean residence time (MRT) o Clearance (CL) o Incremental in vivo recovery (IVR; peak concentration of antithrombin observed within the first hour after infusion) o Volume of distribution at steady state (Vss) o Time to reach Maximum Plasma Concentration (Tmax), • Efficacy Parameters: o Antithrombin activity; o Coagulation parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], international normalised ratio [INR] and fibrinogen), • Safety Parameters: o Adverse events (AEs) and serious AEs (SAEs); o Length of hospital stay; o Vital signs (including systolic and diastolic blood pressure, pulse rate, body temperature, respiration rate, results of physical examination); o Standard haematological and clinical chemistry safety variables, as well as thrombogenicity markers including D-dimer, prothrombin fragment 1 + 2 (F1+2)*, and thrombin-antithrombin complex (TAT)* * if available from local laboratories

Related papers

No related papers found yet.

Papers published before 2008-02-04 may not appear yet. Historical indexing is in progress.

Interventions

DRUGAtenativ 1000 UI/20 ml polvere e solvente per soluzione per infusione endovenosa

DRUGATENATIV 1000 U.I.

DRUGpolvo y disolvente para solución para perfusión

DRUGAtenativ 1000 I.E. - Pulver und Lösungsmittel zur Herstellung einer Injektions- oder Infusionslösung

DRUGAtenativ 50 NE/ml por és oldószer oldatos infúzióhoz vagy injekcióhoz

DRUGAtenativ 1000 I.E. Pulver und Lösungsmittel zur Herstellung einer Infusionslösung

DRUGATENATIV 50 UI/mL

DRUGpoudre et solvant pour solution pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Incidence of the composite of TEs and TEEs in patients with congenital antithrombin deficiency under cover of Atenativ for surgical procedures or parturition to 30 days post treatment initiation.	—

Secondary

Measure	Time frame
• PK parameters: o Area under the curve (AUCnorm(0–∞)) o Maximum plasma concentration (Cmax) o Half-life (t1/2) o Mean residence time (MRT) o Clearance (CL) o Incremental in vivo recovery (IVR; peak concentration of antithrombin observed within the first hour after infusion) o Volume of distribution at steady state (Vss) o Time to reach Maximum Plasma Concentration (Tmax), • Efficacy Parameters: o Antithrombin activity; o Coagulation parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], international normalised ratio [INR] and fibrinogen), • Safety Parameters: o Adverse events (AEs) and serious AEs (SAEs); o Length of hospital stay; o Vital signs (including systolic and diastolic blood pressure, pulse rate, body temperature, respiration rate, results of physical examination); o Standard haematological and clinical chemistry safety variables, as well as thrombogenicity markers including D-dimer, prothrombin fragment 1 + 2 (F1+2)*, and thrombin-antithrombin com	—

Measure

Time frame

• PK parameters: o Area under the curve (AUCnorm(0–∞)) o Maximum plasma concentration (Cmax) o Half-life (t1/2) o Mean residence time (MRT) o Clearance (CL) o Incremental in vivo recovery (IVR; peak concentration of antithrombin observed within the first hour after infusion) o Volume of distribution at steady state (Vss) o Time to reach Maximum Plasma Concentration (Tmax), • Efficacy Parameters: o Antithrombin activity; o Coagulation parameters (activated partial thromboplastin time [aPTT], prothrombin time [PT], international normalised ratio [INR] and fibrinogen), • Safety Parameters: o Adverse events (AEs) and serious AEs (SAEs); o Length of hospital stay; o Vital signs (including systolic and diastolic blood pressure, pulse rate, body temperature, respiration rate, results of physical examination); o Standard haematological and clinical chemistry safety variables, as well as thrombogenicity markers including D-dimer, prothrombin fragment 1 + 2 (F1+2)*, and thrombin-antithrombin com

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Countries

Austria, Czechia, France, Germany, Hungary, Italy, Romania, Spain

Outcome results

None listed