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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: Completed Phase 2 study of Graft-Versus-Host Disease and GvHD, sponsored by John Levine.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of High Risk patients who develop steroid refractory GVHD by day 100 post Hematopoietic cell transplant (HCT) . Steroid refractory GVHD defined as patients who did not achieve Complete Response (CR) or Partial Response (PR) by day 28 of systemic steroid treatment OR if additional immunosuppression beyond steroids was given for treatment of GVHD prior to 28 days of steroid treatment. * CR: All evaluable organs (skin, liver, GI tract) stage 0. For a response to be scored as CR on day 28,
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-08-17 |
| Est. Completion | 2020-08-21 |
| Phase | Phase 2 |
What the finished NCT03459040 record still lists
NCT03459040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 82-participant average among 38 other Graft-Versus-Host Disease trials with a reported enrollment target (63% lower).
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 lists 5 locations in 5 states (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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Where NCT03459040's enrollment target sits among peer trials
30 29th of 38 higher than 8 of 38 other Graft-Versus-Host Disease trials
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