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An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)

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Trial Profile

An Open Label, Multicenter Study to Evaluate the Pharmacokinetics, Efficacy and Safety of ASCENIV™ (IGIV) in Pediatric Subjects With Primary Immunodeficiency Diseases (PIDD)

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 12 Nov 2024

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Agammaglobulinaemia; Immunodeficiency disorders; Type 1 hyper-IgM immunodeficiency syndrome; X-linked genetic disorders
  • Focus Pharmacokinetics
  • Sponsors ADMA Biologics

Most Recent Events

  • 07 Nov 2024 According to a ADMA Biologics media release, all pediatric patients in ASCENIV's post-marketing pediatric study have now successfully completed their treatment schedule and the clinical trial database is on track to be locked in the fourth quarter of 2024. ADMA now anticipates filing its supplemental Biologics License Application (sBLA) over the coming quarters, with potential label-expanding approval in the first half of 2026.
  • 09 May 2024 According to a ADMA Biologics media release, this trial may provide label expansion opportunities
  • 13 Sep 2022 Status changed from not yet recruiting to recruiting.

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