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NCT01700036 · ClinicalTrials.gov registry record · Phase 2
A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease
A Phase 2 study of Graft Vs Host Disease, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 2
- Study locations
NCT01700036 is a Phase 2 study of Graft Vs Host Disease that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 40 participants, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (71% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT01700036, a Phase 2 study of Graft Vs Host Disease, has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 2
- Study locations
Study Summary
This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha 1-Antitrypsin (AAT) medication (also known as an Alpha1-Proteinase Inhibitor \[Human\]) for the treatment of steroid refractory GVHD. For bone marrow transplant patients, the most common, serious complication is Graft vs Host Disease (GVHD), which at its most severe is a life-threatening, complication and a significant cause of treatment related death, following stem cell transplantation. GVHD is a major obstacle to the overall success of transplant treatment, a strategy that would otherwise provide the possibility of a cure for patients with blood cancers or severe blood disorders. GVHD primarily affects the skin, gut, and liver of the recipient, and involves the interaction of the recipient's (the host's) cells and tissues with the donor's immune system cells that see the host tissues as foreign, and attack the host's cells resulting in tissue and organ damage. The severity of acute GvHD ranges from mild to severe, and for patients who don't respond to steroid therapy, the complication is nearly always fatal, either from organ damage or opportunistic infection as a consequence of high dose, steroid treatments. There is currently no known effective therapy for patients with acute graft vs host disease that's refractory (nonresponsive) to steroid therapy. As stated earlier,the overwhelming majority of these patients may ultimately die from infection. The incidence of acute GvHD that requires intervention, is higher for unrelated donor transplants, the most common treatment option available, and therefore, these patients are at higher risk for treatment related complications from GVHD. Approximately 20,000 unrelated donor transplants are performed each year. The magnitude of this problem then is significant for patients who otherwise might be cured of their blood cancer or disease.
Conditions Studied
Interventions
- DRUG Alpha-1-Antitrypsin (AAT)
Study Locations (2)
Massachusetts
- Dana-Farber Cancer Institute - Boston
Michigan
- University of Michigan Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-07 |
| Est. Completion | 2018-10-26 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01700036
The ClinicalTrials.gov registry entry for NCT01700036 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 137-participant average among 36 other Graft Vs Host Disease trials with a reported enrollment target (71% lower). The listed sponsor is University of Michigan Rogel Cancer Center, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Graft Vs Host Disease appearing as the primary indexed condition, and to 1 intervention - of which Alpha-1-Antitrypsin (AAT) is the first listed.
NCT01700036 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT01700036 about?
NCT01700036 is a clinical study titled "A Pilot Study of Alpha-1-Antitrypsin (AAT) in Steroid Refractory Acute Graft vs Host Disease". This clinical trial will study the safety and efficacy of using the drug Zemaira, an Alpha 1-Antitrypsin (AAT) medication (also known as an Alpha1-Proteinase Inhibitor \[Human\]) for the treatment of steroid refractory GVHD. For bone marrow transplant patients, the most common, serious complication...
What is the current status of trial NCT01700036?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2013-07. Estimated completion is 2018-10-26.
What conditions does trial NCT01700036 study?
This clinical trial studies the following conditions: Graft Vs Host Disease.
What interventions are being tested in trial NCT01700036?
The interventions under investigation include: Alpha-1-Antitrypsin (AAT) (DRUG).
Who is sponsoring clinical trial NCT01700036?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01700036 being conducted?
This trial has 2 study locations across Massachusetts, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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