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NCT01750879 · ClinicalTrials.gov registry record · Phase 1
Tolerance Following Peanut Oral Immunotherapy
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 41
- Enrollment target
NCT01750879: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01750879 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 41 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01750879, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 41 participants
- Enrollment target
Study Summary
The unifying objective of this project is to determine whether peanut oral immunotherapy (PN OIT) induced clinical tolerance in the context of food allergy is significantly associated with the expansion of a specific regulatory T cell subset (CD45RA- CD25++ FoxP3++) that is thought to be inducible in the gut-associated lymphoid compartment and associated with immunological tolerance. The hypothesis of the study is that the induction of Treg cells will be associated with clinical tolerance. The investigators will measure the change from baseline of induced Treg cells as a frequency of total CD4 T cells during active treatment and compare that between participants who achieve significant clinical tolerance (Tolerance and Partial Tolerance Groups as defined below) and those who do not (Treatment Failure Group).
Interventions
- DRUG Peanut Flour
- DRUG Oat Flour
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-07-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01750879
The ClinicalTrials.gov registry entry for NCT01750879 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 41 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Peanut Flour is the first listed.
NCT01750879 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01750879 about?
NCT01750879 is a clinical study titled "Tolerance Following Peanut Oral Immunotherapy". The unifying objective of this project is to determine whether peanut oral immunotherapy (PN OIT) induced clinical tolerance in the context of food allergy is significantly associated with the expansion of a specific regulatory T cell subset (CD45RA- CD25++ FoxP3++) that is thought to be inducible i...
What is the current status of trial NCT01750879?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 41 participants. The study started on 2013-08. Estimated completion is 2017-07-11.
What interventions are being tested in trial NCT01750879?
The interventions under investigation include: Peanut Flour (DRUG), Oat Flour (DRUG).
Who is sponsoring clinical trial NCT01750879?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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