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NCT01523821 · ClinicalTrials.gov registry record · Phase 1
Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
NCT01523821: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT01523821 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01523821, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
Study Summary
This phase I/II trial evaluates the efficacy and adverse effects of alpha 1 anti-trypsin (AAT) for the treatment of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation.
Primary Outcome
Toxicity and adverse events were assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0. All adverse events were reported regardless of attribution to alpha 1 anti-trypsin (AAT). GVHD response was defined per standard criteria for improvement, no change or progression of signs/symptoms in skin rash (% body surface area), GI (nausea, vomiting, anorexia, diarrhea, GI bleeding, abdominal cramping) and hepatic function (serum bilirubin levels).
Interventions
- DRUG Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2013-10-11 |
| Est. Completion | 2017-01-15 |
| Phase | Phase 1 |
What the finished NCT01523821 record still lists
NCT01523821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 1 intervention - of which Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia] is the first listed.
NCT01523821 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01523821 about?
NCT01523821 is a clinical study titled "Alpha 1 Anti-Trypsin (AAT) in Treating Patients With Acute Graft-Versus-Host Disease GVHD)". This phase I/II trial evaluates the efficacy and adverse effects of alpha 1 anti-trypsin (AAT) for the treatment of acute graft-versus-host disease (GVHD) after hematopoietic stem cell transplantation.
What is the current status of trial NCT01523821?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2013-10-11. Estimated completion is 2017-01-15.
What interventions are being tested in trial NCT01523821?
The interventions under investigation include: Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia] (DRUG).
Who is sponsoring clinical trial NCT01523821?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01523821's enrollment target sits among peer trials
20 1629th of 2000 higher than 285 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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