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NCT03594331 · ClinicalTrials.gov registry record · Phase 1
Gastric Gluten-Degradation Activity of PvP001
A Phase 1 study, sponsored by Danielle Kim Turgeon.
- Terminated
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03594331: Clinical Trial Phase 1 study, sponsored by Danielle Kim Turgeon.
NCT03594331 is a Phase 1 study that was terminated before completion, run by Danielle Kim Turgeon. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03594331, a Phase 1 study, was terminated before completion, sponsored by Danielle Kim Turgeon.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug PvP001 administered to healthy volunteers (age 18-64 years). Subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single meal. Within each gluten exposure group, increasing doses of PvP001 (or placebo) will be administered.
Primary Outcome
The number of treatment emergent adverse events at each dosage level
Interventions
- DRUG Placebo
- DRUG Low-dose PvP001
- DRUG Medium-dose PvP001
- DRUG High-dose PvP001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-05-25 |
| Est. Completion | 2019-02-06 |
| Phase | Phase 1 |
Why NCT03594331 stopped before completion
NCT03594331 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03594331 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03594331 about?
NCT03594331 is a clinical study titled "Gastric Gluten-Degradation Activity of PvP001". This is a single blind, dose escalating, placebo-controlled, crossover study of gluten-degrading drug PvP001 administered to healthy volunteers (age 18-64 years). Subjects will be randomized to one of three groups representing different levels of gluten exposure - low, medium, or high - in a single ...
What is the current status of trial NCT03594331?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2018-05-25. Estimated completion is 2019-02-06.
What interventions are being tested in trial NCT03594331?
The interventions under investigation include: Placebo (DRUG), Low-dose PvP001 (DRUG), Medium-dose PvP001 (DRUG), High-dose PvP001 (DRUG).
Who is sponsoring clinical trial NCT03594331?
This trial is sponsored by Danielle Kim Turgeon, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03594331's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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