Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study of Celiac Disease, sponsored by Regeneron Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Change in the T-cell receptor repertoire (measured by T cell receptor sequencing) in the small intestine after gluten challenge
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 |
What the finished NCT04614571 record still lists
NCT04614571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,979-participant average among 24 other Celiac Disease trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Celiac Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04614571's enrollment target sits among peer trials
24 22nd of 24 higher than 3 of 24 other Celiac Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Celiac Disease 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
-
Tissue Destruction and Healing in Celiac Disease
RECRUITING · NA
-
Immune Responses to Gluten
RECRUITING · NA
-
Gluten Technology and Education for Celiac Health
RECRUITING · NA
-
Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System
COMPLETED · NA
-
Changes in Intestinal Permeability 4 Hours After Gluten Challenge
COMPLETED · NA
-
Celiac Disease Genomic Environmental Microbiome and Metabolomic Study
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI