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Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases

Trial Profile

Clinical Phase III Study to Evaluate the Pharmacokinetics, Efficacy, Tolerability and Safety of Subcutaneous Human Immunoglobulin (Octanorm 16.5%) In Patients With Primary Immunodeficiency Diseases

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Sep 2019

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At a glance

  • Drugs Immune globulin (Primary)
  • Indications Bacteraemia; Bacterial infections; Bacterial meningitis; Immunodeficiency disorders; Infectious arthritis; Osteomyelitis; Sepsis
  • Focus First in man; Pharmacokinetics; Registrational; Therapeutic Use
  • Sponsors Octapharma
  • Most Recent Events

    • 27 Aug 2019 Planned End Date changed from 1 Dec 2019 to 1 Jul 2020.
    • 27 Aug 2019 Planned primary completion date changed from 1 Dec 2019 to 1 Jul 2020.
    • 06 May 2019 Primary endpoint has been met. (To assess the efficacy of octanorm in preventing serious bacterial infections (SBI))
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