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NCT03459040 · ClinicalTrials.gov registry record · Phase 2

A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD

A Phase 2 study of Graft-Versus-Host Disease and GvHD, sponsored by John Levine.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target
5
Study locations

NCT03459040 is a Phase 2 study of Graft-Versus-Host Disease and GvHD that has completed, run by John Levine. The registered enrollment target is 30 participants, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (63% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT03459040, a Phase 2 study of Graft-Versus-Host Disease and GvHD, has completed, sponsored by John Levine.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target
5
Study locations

Study Summary

Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious and potentially fatal complication. The researchers have developed a blood test to identify patients most at risk for developing severe GVHD. Patients who consent to this study will have their blood tested up to two times after BMT to determine if they are at high risk for severe GVHD. The tests will be performed one week and two weeks after BMT. Patients who are high risk will be treated with a drug called alpha-1-antitrypsin (AAT) to see if it prevents the development of severe GVHD. Patients will receive 16 doses of AAT through a catheter placed into a blood vessel over eight weeks. AAT will be given either in the hospital or the outpatient clinic two times per week. Patients will be followed for the development of severe GVHD for up to four months from the BMT and will continue to be followed at routine clinic visits for up to one year after BMT.

Conditions Studied

Graft-Versus-Host Disease GvHD

Interventions

  • DRUG Alpha 1-Antitrypsin

Study Locations (5)

California

  • City of Hope - Duarte

Massachusetts

  • Massachusetts General Hospital - Boston

New York

  • Icahn School of Medicine at Mount Sinai - New York

Ohio

  • Ohio State University - Columbus

Tennessee

  • Vanderbilt University - Nashville

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2018-08-17
Est. Completion 2020-08-21
Phase Phase 2

Sponsor

John Levine

5 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03459040

The ClinicalTrials.gov registry entry for NCT03459040 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (63% lower). The listed sponsor is John Levine, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Graft-Versus-Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Alpha 1-Antitrypsin is the first listed.

NCT03459040 reports 5 study locations spanning 5 distinct geographic areas - top geographies include California, Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT03459040 about?

NCT03459040 is a clinical study titled "A Proof of Concept Pilot Trial of Alpha-1-Antitrypsin for Pre-Emption Of Steroid-Refractory Acute GVHD". Bone marrow transplant (BMT) patients can develop graft-versus-host disease (GVHD), a serious and potentially fatal complication. The researchers have developed a blood test to identify patients most at risk for developing severe GVHD. Patients who consent to this study will have their blood tested ...

What is the current status of trial NCT03459040?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2018-08-17. Estimated completion is 2020-08-21.

What conditions does trial NCT03459040 study?

This clinical trial studies the following conditions: Graft-Versus-Host Disease, GvHD.

What interventions are being tested in trial NCT03459040?

The interventions under investigation include: Alpha 1-Antitrypsin (DRUG).

Who is sponsoring clinical trial NCT03459040?

This trial is sponsored by John Levine, which has 5 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03459040 being conducted?

This trial has 5 study locations across California, Massachusetts, New York, Ohio, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.