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A Two-Part, Multi-Center, Prospective, Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of GLASSIA as an Add-On Biopharmacotherapy to Conventional Steroid Treatment in Subjects With Acute Graft-Versus-Host Disease With Lower Gastrointestinal Involvement

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A Two-Part, Multi-Center, Prospective, Phase 2/3 Clinical Study to Evaluate the Safety and Efficacy of GLASSIA as an Add-On Biopharmacotherapy to Conventional Steroid Treatment in Subjects With Acute Graft-Versus-Host Disease With Lower Gastrointestinal Involvement

Status: Discontinued
Phase of Trial: Phase II/III

Latest Information Update: 26 Jun 2019

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At a glance

  • Drugs Alpha 1-antitrypsin (Primary) ; Methylprednisolone (Primary) ; Methylprednisolone (Primary) ; Albumin human
  • Indications Graft-versus-host disease
  • Focus Therapeutic Use
  • Sponsors Baxalta; Shire

    • Most Recent Events

    • 30 May 2018 Status changed from active, no longer recruiting to discontinued.
    • 12 Mar 2018 Status changed from suspended to active, no longer recruiting.
    • 07 Jun 2017 According to a Kamada media release, as a result of the transfer of IND, the current Part 1 of the Phase 2/3 study conducted in the U.S. is being halted by Shire. Kamada intends to resume the development program in the upcoming few months upon completion of standardizing the study design across both the U.S. and EU, based on the feedback already received from the FDA and the European Medicines Agency (EMA).

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