A Phase I, Dose Escalation Study on the Safety, Pharmacokinetics and Pharmacodynamics of Coagulation Factor VIIa (Recombinant) and its Comparability to NovoSeven® in Healthy Male Volunteers Pre-Treated with Fondaparinux

Completed

• Conditions: haemophilia; 10064477

• Registration Number: NL-OMON34613
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 36

Inclusion Criteria

Healthy male volunteers, 19-45 years of age, BMI 19-30 kg/m^2

Exclusion Criteria

Bleeding or coagulation disorder, recent trauma, thromboembolic event, history of administration of any rhFVIIa product, positive reaction to rabbit allergens. See protocol for detailed list of exclusion criteria.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics of FVIIa (activity and FVIIa antigen)<br /><br><br /><br>Pharmacodynamics of FVIIa:<br /><br>- Thrombin generation assay output (AUC: primary variable);<br /><br>- activated partial thromboplastin time (aPTT);<br /><br>- prothrombin time (PT);<br /><br>- FVIIa activity;<br /><br>- anti-Xa;<br /><br>- Prothrombin fragments 1+2 (F1+2);<br /><br>- D-dimer;<br /><br>- fibrinogen;<br /><br>- antithrombin;<br /><br>- thrombin antithrombin complex (TAT)<br /><br><br /><br>Safety:<br /><br>Physical examinations, ECGs, vital signs, clinical laboratory tests, immunology<br /><br>tests, and monitoring of adverse events, coagulation parameters.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>see above</p><br>