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

Trial Profile

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

Suspended
Phase of Trial: Phase II/III

Latest Information Update: 26 Oct 2017

At a glance

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

    • 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).
    • 07 Jun 2017 According to a Kamada media release, Shire decided to transfer the IND to Kamada due to pipeline prioritization and slow recruitment rate in its current U.S. study. Kamada will assume control of, and onward funding for the full G1-AAT IV program, and intends to conduct an integrated clinical development program across both territories - the U.S. and the EU.
    • 07 Jun 2017 According to a Kamada media release, the Investigational New Drug (IND) application for this Phase 2/3 study will be transferred from Shire to Kamada, who will take full ownership and responsibility for the clinical development of the product in this indication.
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