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NCT04054544 · ClinicalTrials.gov registry record · Early Phase 1
Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)
A Early Phase 1 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 18
- Enrollment target
NCT04054544: Completed Early Phase 1 study, sponsored by Merck Sharp & Dohme.
NCT04054544 is a Early Phase 1 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 18 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04054544, a Early Phase 1 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This is a gluten challenge study to characterize peripheral blood and intestinal gluten specific cluster of differentiation 4 glycoprotein (CD4+) thymus lymphocyte (T cell) subsets in participants with Celiac Disease
Primary Outcome
Peripheral blood mononuclear cells (PBMC) collected prior to gluten challenge were stained with phycoerythrin (PE)-labeled human leukocyte antigen (HLA)-DQ2.5: gluten tetramers (DQ2.5-glia-α1 and DQ2.5-glia-α2) to identify antigen-specific cluster of differentiation (CD)4-positive thymus lymphocyte (T cells) reactive to gliadin (tetramer+ T cells) by flow cytometry. PBMC were also labeled with a 20-antibody panel for cell surface antigen staining to further define tetramer+ T cell subsets. Antig
Interventions
- DIETARY_SUPPLEMENT Gluten powder 4g
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-08-28 |
| Est. Completion | 2021-06-23 |
| Phase | Early Phase 1 |
What the finished NCT04054544 record still lists
NCT04054544 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 1 intervention - of which Gluten powder 4g is the first listed.
NCT04054544 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04054544 about?
NCT04054544 is a clinical study titled "Gluten Challenge Study in Celiac Disease Participants (MK-0000-402)". This is a gluten challenge study to characterize peripheral blood and intestinal gluten specific cluster of differentiation 4 glycoprotein (CD4+) thymus lymphocyte (T cell) subsets in participants with Celiac Disease
What is the current status of trial NCT04054544?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 18 participants. The study started on 2020-08-28. Estimated completion is 2021-06-23.
What interventions are being tested in trial NCT04054544?
The interventions under investigation include: Gluten powder 4g (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04054544?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04054544's enrollment target sits among peer trials
18 1316th of 2000 higher than 651 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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