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Open label phase III safety, efficacy, and pharmacokinetic study of NABI-IGIV [immunoglobulins] 10% [immune globulin intravenous (human)] in subjects with primary immune deficiency disorders (PIDD)

Trial Profile

Open label phase III safety, efficacy, and pharmacokinetic study of NABI-IGIV [immunoglobulins] 10% [immune globulin intravenous (human)] in subjects with primary immune deficiency disorders (PIDD)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Immunoglobulin G (Primary)
  • Indications Immunodeficiency disorders
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Biotest Pharmaceuticals
  • Most Recent Events

    • 12 Dec 2023 According to a Biotest media release, the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application submitted under section 351(a) of the Public Health Service Act for BIVIGAM. The FDA approval represents the final study report for the Pediatric assessment as required in the post marketing commitment. Additionally, the approval provides for a revision of BIVIGAM's prescribing information to expand the primary humoral immunodeficiency.
    • 11 Apr 2012 Primary endpoint 'Infection-rate' has been met, according to a Biotest AG media release.
    • 11 Apr 2012 Results were published in the Journal of Clinical Immunology, according to a Biotest AG media release.
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