Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
Public ClinicalTrials.gov record NCT04167514. 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 Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 - Antitrypsin (AAT) Combined With Corticosteroids vs Corticosteroids Alone for the Treatment of High Risk Acute Graft-versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Study CSL964\_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD
Study identification
- NCT ID
- NCT04167514
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 136 participants
Conditions and interventions
Conditions
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
- Jan 9, 2020 (Actual)
- Primary completion
- Sep 11, 2023 (Actual)
- Completion
- Jun 26, 2024 (Actual)
- Last update posted
- Jul 28, 2026
2020 – 2024
United States locations
- U.S. sites
- 25
- U.S. states
- 18
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | — |
| University of Florida | Gainesville | Florida | 32608 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Emory University | Atlanta | Georgia | 30322-1059 | — |
| Northside Hospital | Atlanta | Georgia | 30342 | — |
| IU Hospital | Indianapolis | Indiana | 46202 | — |
| Univ. of Kansas Cancer Center | Westwood | Kansas | 66205 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| U-M Medical Center | Ann Arbor | Michigan | 48109-0312 | — |
| Karmanos Cancer Center | Detroit | Michigan | 48201 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Washington University | St Louis | Missouri | 63110 | — |
| MSKCC | New York | New York | 10065 | — |
| Levine Cancer Center | Charlotte | North Carolina | 28204 | — |
| Duke | Durham | North Carolina | 27705 | — |
| Cleveland Clinic | Cleveland | Ohio | 44124 | — |
| Ohio State Univ.Medical Center | Columbus | Ohio | 43210 | — |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Center for Gene Therapy | Houston | Texas | 77030 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Virginia Commonwealth Univ. | Richmond | Virginia | 23298 | — |
| Fred Hutchinson Clinic | Seattle | Washington | 98109 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04167514, 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 Jul 28, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04167514 live on ClinicalTrials.gov.