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NCT04524221 · ClinicalTrials.gov registry record · Phase 1
PTG-100 for Patients With Celiac Disease
A Phase 1 study of Celiac Disease, sponsored by Nielsen Fernandez-Becker.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04524221: Completed Phase 1 study of Celiac Disease, sponsored by Nielsen Fernandez-Becker.
NCT04524221 is a Phase 1 study of Celiac Disease that has completed, run by Nielsen Fernandez-Becker. The registered enrollment target is 12 participants, below the 1,980-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
NCT04524221, a Phase 1 study of Celiac Disease, has completed, sponsored by Nielsen Fernandez-Becker.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten. This is a clinical research study to determine the safety and efficacy of PTG-100 in preventing gluten-induced inflammatory injury to the small intestine in patients with celiac disease. 30 patients will receive either placebo (fake drug) or PTG-100 (real drug) in capsule form twice daily for 42 days. They will also receive a gluten challenge twice daily in the form of a cookie or equivalent. An upper gastrointestinal endoscopy and exam including small bowel mucosa biopsy will be performed at the start of the treatment period and again at the end. Blood samples will be routinely taken to evaluate safety and the drug's mechanism of action throughout the study, and symptoms will be recorded using the celiac symptoms index (CSI) survey.
Primary Outcome
Percentage change from baseline to Week 6 in villous height-to crypt depth (Vh:Cd) ratio
Conditions Studied
Interventions
- DRUG Placebo
- DRUG PTG-100
Study Locations (1)
California
- Stanford University - Redwood City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-02-26 |
| Est. Completion | 2022-04-03 |
| Phase | Phase 1 |
What the finished NCT04524221 record still lists
NCT04524221 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,980-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 2 interventions - of which Placebo is the first listed.
NCT04524221 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04524221 about?
NCT04524221 is a clinical study titled "PTG-100 for Patients With Celiac Disease". The goal of this study is to learn whether or not the drug PTG-100 can reduce or prevent inflammatory injury to the small intestine that occurs when people with celiac disease eat food products containing gluten. This is a clinical research study to determine the safety and efficacy of PTG-100 in p...
What is the current status of trial NCT04524221?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-02-26. Estimated completion is 2022-04-03.
What conditions does trial NCT04524221 study?
This clinical trial studies the following conditions: Celiac Disease.
What interventions are being tested in trial NCT04524221?
The interventions under investigation include: Placebo (DRUG), PTG-100 (DRUG).
Who is sponsoring clinical trial NCT04524221?
This trial is sponsored by Nielsen Fernandez-Becker, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04524221 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04524221's enrollment target sits among peer trials
12 24th of 24 the lowest 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.
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