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NCT04152473 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Oral Proglumide for NASH
A Phase 1 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
NCT04152473 is a Phase 1 study that has completed, run by Georgetown University. The registered enrollment target is 18 participants.
The verdict
NCT04152473, a Phase 1 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study is an open labelled Phase I/II clinical trial, designed to evaluate the safety and efficacy of an oral cholecystokinin (CCK) receptor antagonist, proglumide, at escalating doses in subjects with NASH. An extended use protocol has been approved for subjects completing this study that show benefit or are at risk of Liver disease progression to continue on Proglumide at 1200 mg / day for an additional 3-9 months. Subjects in the extended protocol will have telephone visits monthly and in the research unit every 3 months for safety lab tests and research blood for fibrosis analysis.
Interventions
- DRUG Proglumide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-12-13 |
| Est. Completion | 2022-09-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04152473
The ClinicalTrials.gov registry entry for NCT04152473 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Proglumide is the first listed.
NCT04152473 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04152473 about?
NCT04152473 is a clinical study titled "Safety and Tolerability of Oral Proglumide for NASH". This study is an open labelled Phase I/II clinical trial, designed to evaluate the safety and efficacy of an oral cholecystokinin (CCK) receptor antagonist, proglumide, at escalating doses in subjects with NASH. An extended use protocol has been approved for subjects completing this study that show...
What is the current status of trial NCT04152473?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2019-12-13. Estimated completion is 2022-09-09.
What interventions are being tested in trial NCT04152473?
The interventions under investigation include: Proglumide (DRUG).
Who is sponsoring clinical trial NCT04152473?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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