Multi-center, Randomized, Open-label, Parallel-arm, Single-dose, Pharmacokinetic Study of rVIIa-FP (CSL689) in Subjects with Congenital Factor VII Deficiency

Multi-center, Randomized, Open-label, Parallel-arm, Single-dose, Pharmacokinetic Study of rVIIa-FP (CSL689) in Subjects with Congenital Factor VII Deficiency - CSL689_1002 PK and safety study in patients with congenital FVII deficiency

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON43708

Enrollment

Registered

2014-11-27

Start date

2015-07-08

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Factor VII Deficiency

Interventions

Single dose of either NovoSeven (25 µg/kg) or pdFVII (30 IU/kg) and Single dose of CSL689 (100 or 300 µg/kg)

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - subjects with proven congenital factor VII deficiency - age >= 18 years. - FVII level

Exclusion criteria

Exclusion criteria: - History of, or risk factors for, thromboembolic events, including known deep vein thrombosis - Inhibitor to FVII or rFVIIa, current or historic. - Known or suspected hypersensitivity to hamster protein, to CSL689, or to any excipient of CSL689. - Known or suspected allergy to rFVIIa or hamster protein. - Major surgery within 1 month before screening or scheduled major and / or orthopedic surgery during the study. - Advanced atherosclerotic disease (ie, known history of ischemic heart disease, or ischemic stroke) - Human immunodeficiency virus (HIV)-positive subjects with cluster of differentiation 4 (CD4) + lymphocyte count of

Design outcomes

Primary

Measure	Time frame
- Elimination half-life of plasma factor VIIa activity - Maximum observed plasma FVIIa activity - Area under the curve (AUC0-t), Area under plasma factor VIIa activity versus time curve from time 0 to last sample with quantifiable activity	—

Secondary

Measure	Time frame
- Total clearance, Total clearance of plasma factor VIIa activity - AUC(0-inf), Area under plasma factor VIIa activity versus time curve from time 0 extrapolated to infinity - Incremental recovery, Incremental recovery of plasma factor VIIa activity - Time of occurrence of maximum observed plasma FVIIa activity - Number of subjects with antibodies against CSL689 - Number of subjects with inhibitors against CSL689	—

Measure

Time frame

- Total clearance, Total clearance of plasma factor VIIa activity - AUC(0-inf), Area under plasma factor VIIa activity versus time curve from time 0 extrapolated to infinity - Incremental recovery, Incremental recovery of plasma factor VIIa activity - Time of occurrence of maximum observed plasma FVIIa activity - Number of subjects with antibodies against CSL689 - Number of subjects with inhibitors against CSL689

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)