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This study compares the use of Alpha-1 antitrypsin (AAT) together with corticosteroids against corticosteroids alone for treating graft-versus-host disease (GVHD) that develops after stem cell transplantation. It enrolled patients aged 12 and over who developed acute GVHD requiring systemic treatment after allogeneic hematopoietic stem cell transplantation. The study was conducted in Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Patients 12 years of age or older * Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication * Any graft or donor source or conditioning intensity * Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids Exclusion Criteria: * Prior exogenous AAT exposure for GVHD prophylaxis * Relapsed, progressing, or persistent malignancy * de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment * Receiving other drugs for the treatment of GVHD * Receiving systemic CS for any indication within 7 days before the onset of acute GVHD