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A Phase 3, Multicenter, Open-label, Single-sequence, Cross-over, Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of IVIG-PEG Compared to Gamunex-C in Subjects With Primary Humoral Immunodeficiency

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A Phase 3, Multicenter, Open-label, Single-sequence, Cross-over, Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of IVIG-PEG Compared to Gamunex-C in Subjects With Primary Humoral Immunodeficiency

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2023

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Immunodeficiency disorders
  • Focus Pharmacokinetics
  • Sponsors Grifols

    • Most Recent Events

    • 07 Jun 2022 Status changed from active, no longer recruiting to completed.
    • 27 Jan 2022 Status changed from recruiting to active, no longer recruiting.
    • 26 Aug 2021 Planned number of patients changed from 25 to 35.

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