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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 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.

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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).

Conditions Studied

Acute-graft-versus-host Disease

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

FieldValue
Enrollment Target 222 participants
Start Date 2019-03-27
Est. Completion 2026-03-31
Phase Phase 2

Sponsor

CSL Behring

71 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03805789

The ClinicalTrials.gov registry entry for NCT03805789 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 76-participant average among 7 other Acute-graft-versus-host Disease trials with a reported enrollment target (192% higher). The listed sponsor is CSL Behring, which has 71 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 15 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.