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Clinical Trials/NL-OMON43708
NL-OMON43708CompletedNot Applicable

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

CSL Behring GmbH0 sites9 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
9
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

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]

Investigators

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