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ACTIVE NOT RECRUITING 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

NCT03805789 · View on ClinicalTrials.gov ↗

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).

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

85 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03805789 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, Arizona, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03805789?

The interventions under investigation include: Placebo (BIOLOGICAL), AAT (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03805789?

This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial