The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
Public ClinicalTrials.gov record NCT03805789. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2/3, Multicenter, randOmized, Double-blind, Placebo-controlled, stUdy to evaLuate the Safety and Efficacy of Alpha-1 AntiTrypsin for the prEvention of Graft-versus-host Disease in Patients Receiving Hematopoietic Cell Transplant (MODULAATE Study)
Study identification
- NCT ID
- NCT03805789
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Lead sponsor
- CSL Behring
- Industry
- Enrollment
- 222 participants
Conditions and interventions
Conditions
Interventions
- AAT Biological
- Placebo Biological
Biological
Eligibility (public fields only)
- Age range
- 12 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 26, 2019
- Primary completion
- Mar 18, 2026
- Completion
- Mar 18, 2026
- Last update posted
- Apr 21, 2026
2019 – 2026
United States locations
- U.S. sites
- 12
- U.S. states
- 12
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Scottsdale Shea Medical Center | Scottsdale | Arizona | 85258 | — |
| Johns Hopkins Hospital | St. Petersburg | Florida | 33701 | — |
| Emory University | Atlanta | Georgia | 30322 | — |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| University Hospital Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The University of Texas-MD Anderson Cancer Center | San Antonio | Texas | 77030 | — |
| University of Utah Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 22 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03805789, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 21, 2026 · Synced May 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03805789 live on ClinicalTrials.gov.