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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON34613

Enrollment

Registered

2010-10-05

Start date

2011-01-10

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haemophilia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
see above	—

Countries

Netherlands

Outcome results