drugset / Trial / NCT02956122

A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD

NCT02956122

Phase 2/3 Terminated 1 enrolled Baxalta now part of Shire Kamada, Ltd. · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI involvement.

Timeline

Start
2017-04-26
Primary completion
2018-05-03
Completion
2018-05-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpha 1-Antitrypsin Protein / enzyme biologic Intravenous
Background Methylprednisolone Other / unclassified Intravenous