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Clinical Trials/DRKS00015079
DRKS00015079
Completed
N/A

A prospective, non-interventional study to investigate the effectiveness of a recombinant fusion protein linking coagulation Factor IX with recombinant albumin (rIX-FP) in patients with hemophilia B

CSL Behring GmbH0 sites73 target enrollmentAugust 7, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
D67
Sponsor
CSL Behring GmbH
Enrollment
73
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 7, 2018
End Date
March 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Factor IX deficiency.
  • Treatment with IDELVION® according to routine practice and according to the current SmPC (The decision for IDELVION® therapy was made independent of this NIS)
  • Written and personally dated informed consent of the patient or in case of minors of one parent or legal guardian after receiving detailed information about the observational study by the treating physician. Minors should also sign the informed consent, if his/her age allows it.

Exclusion Criteria

  • Existing inhibitor development.
  • Existing multi\-factor\-deficiency
  • simultaneous participation in an interventional study
  • Known hypersensitivity to any ingredient of the FIX product or hamster protein

Outcomes

Primary Outcomes

Not specified

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