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NCT03805789 · ClinicalTrials.gov registry record · Phase 2
The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant
A Phase 2 study of Acute-graft-versus-host Disease, sponsored by CSL Behring.
- Active
- Registry status
- Phase 2
- Development phase
- 222
- Enrollment target
- 20
- Study locations
NCT03805789: Active Phase 2 study of Acute-graft-versus-host Disease, sponsored by CSL Behring.
NCT03805789 is a Phase 2 study of Acute-graft-versus-host Disease that is active but no longer recruiting, run by CSL Behring. The registered enrollment target is 222 participants, above the 76-participant average among 7 other Acute-graft-versus-host Disease trials with a reported enrollment target (192% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03805789, a Phase 2 study of Acute-graft-versus-host Disease, is active but no longer recruiting, sponsored by CSL Behring.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 222 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
Acute GVHD will be assessed using the Harris scoring system.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL AAT
Study Locations (20)
Other
- Uniklinik Köln - Cologne
- Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli - Calabria
- Anjo Kosei Hospital - Anjo-shi
- Tokyo Metropolitan Komagome Hospital - Bunkyō City
- Hiroshima University Kasumi Campus - Hiroshima
- Aichi Medical Center Nagoya Daiichi Hospital - Nagoya
Arizona
- HonorHealth Scottsdale Shea Medical Center - Scottsdale
Florida
- Johns Hopkins Hospital - St. Petersburg
Georgia
- Emory University - Atlanta
Kansas
- University of Kansas Cancer Center - Westwood
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- University of Michigan Medical Center - Ann Arbor
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2019-03-27 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 2 |
What the registry record for NCT03805789 still lists
NCT03805789 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 76-participant average among 7 other Acute-graft-versus-host Disease trials with a reported enrollment target (192% higher).
The record links to 1 condition, with Acute-graft-versus-host Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03805789 names 20 study sites across 15 states, led by Other, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT03805789 about?
NCT03805789 is a clinical study titled "The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant". 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).
What is the current status of trial NCT03805789?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2019-03-27. Estimated completion is 2026-03-31.
What conditions does trial NCT03805789 study?
This clinical trial studies the following conditions: Acute-graft-versus-host Disease.
What interventions are being tested in trial NCT03805789?
The interventions under investigation include: Placebo (BIOLOGICAL), AAT (BIOLOGICAL).
Who is sponsoring clinical trial NCT03805789?
This trial is sponsored by CSL Behring, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03805789 being conducted?
This trial has 20 study locations across Arizona, Florida, Georgia, Kansas, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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