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

Completed

• Conditions: Factor VII Deficiency; Congenital coagulation factor VII deficiency; 10005330

• Registration Number: NL-OMON43708
• Lead Sponsor: CSL Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 9

Inclusion Criteria

- subjects with proven congenital factor VII deficiency
- age >= 18 years.
- FVII level < 2%.
- minimum of 50 previous exposure days to plasma-derived factor VII or
recombinant factor VIIa

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 < 200/ µL at screening.
- Use of an investigational agent within 30 days before the study
- Use of concomitant therapy not permitted during the study (ie, other platelet inhibitors, desmopressin, fibrinolysis inhibitors, except if used as local treatment [eg, for oral bleeds]

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Elimination half-life of plasma factor VIIa activity<br /><br>- Maximum observed plasma FVIIa activity<br /><br>- Area under the curve (AUC0-t), Area under plasma factor VIIa activity versus<br /><br>time curve from time 0 to last sample with quantifiable activity</p><br>

Secondary Outcome Measures

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