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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 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2026-04-22

No results posted yet for this study

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).

Conditions

  • Acute-graft-versus-host Disease

Interventions

BIOLOGICAL

AAT

AAT is a lyophilized product for IV administration.

BIOLOGICAL

Placebo

Albumin solution administered intravenously

Sponsors & Collaborators

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Study Physician · CSL Behring

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2026-03-19
Completion
2026-03-19
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Germany
  • Italy
  • Japan
  • South Korea
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03805789 on ClinicalTrials.gov