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NCT04614571 · ClinicalTrials.gov registry record · NA
T Cell Receptor (TCR) Sequencing and Transcriptional Profiling in Adult Celiac Disease Patients Undergoing Gluten Challenge
A NA study of Celiac Disease, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04614571 is a NA study of Celiac Disease that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 24 participants, below the 1,979-participant average among 24 other Celiac Disease trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04614571, a NA study of Celiac Disease, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objectives are: * Characterize the T cell receptor (TCR) repertoire in duodenal biopsy samples of participants pre- and post-challenge. * Compare for each patient the TCR repertoire of duodenal biopsy samples with the peripheral blood TCR repertoire of each study participant * Characterize the transcriptome of duodenal biopsy samples and blood from study participants pre- and post-challenge The secondary objectives are: * Ex vivo identification and validation of DQ-restricted gliadin specific TCRs. * Characterize the gluten-challenge induced changes in small intestine histology using standard for Celiac Disease (CeD) histological assessments
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Gluten Powder
Study Locations (1)
Massachusetts
- Celiac Research Centre Mass General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-11-02 |
| Est. Completion | 2024-05-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04614571
The ClinicalTrials.gov registry entry for NCT04614571 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,979-participant average among 24 other Celiac Disease trials with a reported enrollment target (99% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Celiac Disease appearing as the primary indexed condition, and to 1 intervention - of which Gluten Powder is the first listed.
NCT04614571 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT04614571 about?
NCT04614571 is a clinical study titled "T Cell Receptor (TCR) Sequencing and Transcriptional Profiling in Adult Celiac Disease Patients Undergoing Gluten Challenge". The primary objectives are: * Characterize the T cell receptor (TCR) repertoire in duodenal biopsy samples of participants pre- and post-challenge. * Compare for each patient the TCR repertoire of duodenal biopsy samples with the peripheral blood TCR repertoire of each study participant * Character...
What is the current status of trial NCT04614571?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2020-11-02. Estimated completion is 2024-05-30.
What conditions does trial NCT04614571 study?
This clinical trial studies the following conditions: Celiac Disease.
What interventions are being tested in trial NCT04614571?
The interventions under investigation include: Gluten Powder (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04614571?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04614571 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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