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NCT01980992 · ClinicalTrials.gov registry record · Phase 1
Oral Immunotherapy for Wheat Allergy
A Phase 1 study, sponsored by Hugh A Sampson, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 46
- Enrollment target
NCT01980992: Completed Phase 1 study, sponsored by Hugh A Sampson, MD.
NCT01980992 is a Phase 1 study that has completed, run by Hugh A Sampson, MD. The registered enrollment target is 46 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01980992, a Phase 1 study, has completed, sponsored by Hugh A Sampson, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 46 participants
- Enrollment target
Study Summary
This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after stopping the study treatment.
Primary Outcome
Determine in wheat allergic children, whether relative to placebo, daily oral administration of Vital Wheat Gluten escalated to a maximum of 2035 mg/day of Vital Wheat Gluten increases desensitization as measured by consuming without dose limiting symptoms 4443 mg of wheat protein on a 7443 mg wheat protein OFC performed 1 year after initiating treatment.
Interventions
- DRUG Wheat OIT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2013-10 |
| Est. Completion | 2017-04-13 |
| Phase | Phase 1 |
What the finished NCT01980992 record still lists
NCT01980992 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (23% lower).
The record links to 0 conditions, and to 1 intervention - of which Wheat OIT is the first listed.
NCT01980992 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01980992 about?
NCT01980992 is a clinical study titled "Oral Immunotherapy for Wheat Allergy". This study is being done to learn about the medical effects, the safety, and the immunologic effects of Wheat Oral Immunotherapy (OIT) treatment. The goal of the study is to find out whether subjects can develop the ability to eat wheat (the food allergen) regularly without allergic symptoms after s...
What is the current status of trial NCT01980992?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2013-10. Estimated completion is 2017-04-13.
What interventions are being tested in trial NCT01980992?
The interventions under investigation include: Wheat OIT (DRUG).
Who is sponsoring clinical trial NCT01980992?
This trial is sponsored by Hugh A Sampson, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01980992's enrollment target sits among peer trials
46 1058th of 2000 higher than 935 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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