drugset / Trial / NCT03805789

The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant

NCT03805789 ↗

Phase 2/3 Completed 222 enrolled CSL Behring
RandomizedSequentialQuadruple-blindPrevention

Summary

This study is a phase 2 / 3 prospective, double-blind, randomized, multicenter, placebo-controlled study for prevention of acute GVHD (aGVHD) in participants undergoing an unrelated (matched or single allele mismatched) or matched related allogeneic hematopoietic cell transplantation (HCT).

Timeline

Start
2019-03-27
Primary completion
2026-03-19
Completion
2026-03-19

Drugs

EvaluationDrugModalityDoseRoute
Subject AAT Protein / enzyme biologic — Intravenous