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NCT01373242 · ClinicalTrials.gov registry record · Phase 1
Sublingual Immunotherapy for Peanut Allergy and Induction of Tolerance
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
NCT01373242: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01373242 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01373242, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
Study Summary
The goal of this study will be to increase the reaction threshold (desensitization) of peanut allergic children using peanut sublingual immunotherapy and to determine if the nonreactive state of the immune system persists after treatment has been discontinued (tolerance).
Primary Outcome
An estimate of the dose as assessed by the 48th month DBPCFC reported in mg peanut protein, also called population sensitization threshold, predicted to provoke reactions in 5% of the peanut-allergic population. This will also give population level no observed adverse event level (NOAEL) and lowest observed adverse event level (LOAEL) that would define interval of consecutive administered dose levels within which the population sensitization threshold lies. NOAEL is the highest dose observed not
Interventions
- DRUG Liquid peanut extract (Peanut SLIT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2011-06 |
| Est. Completion | 2018-04-16 |
| Phase | Phase 1 |
What the finished NCT01373242 record still lists
NCT01373242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 1 intervention - of which Liquid peanut extract (Peanut SLIT) is the first listed.
NCT01373242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01373242 about?
NCT01373242 is a clinical study titled "Sublingual Immunotherapy for Peanut Allergy and Induction of Tolerance". The goal of this study will be to increase the reaction threshold (desensitization) of peanut allergic children using peanut sublingual immunotherapy and to determine if the nonreactive state of the immune system persists after treatment has been discontinued (tolerance).
What is the current status of trial NCT01373242?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2011-06. Estimated completion is 2018-04-16.
What interventions are being tested in trial NCT01373242?
The interventions under investigation include: Liquid peanut extract (Peanut SLIT) (DRUG).
Who is sponsoring clinical trial NCT01373242?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01373242's enrollment target sits among peer trials
54 931st of 2000 higher than 1,053 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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