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NCT03436420 · ClinicalTrials.gov registry record · Phase 2
Gemcabene for the Treatment of Pediatric NAFLD
A Phase 2 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 6
- Enrollment target
NCT03436420 is a Phase 2 study that was terminated before completion, run by Emory University. The registered enrollment target is 6 participants.
The verdict
NCT03436420, a Phase 2 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 6 participants
- Enrollment target
Study Summary
This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by lifestyle changes. The hypothesis of the study is that 300 mg of gemcabene once a day for 12 weeks will reduce alanine aminotransferase (ALT), hepatic steatosis, dyslipidemia and down regulate de novo lipogenesis in children with NAFLD.
Interventions
- DRUG Gemcabene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2018-03-29 |
| Est. Completion | 2019-08-27 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03436420
The ClinicalTrials.gov registry entry for NCT03436420 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Gemcabene is the first listed.
NCT03436420 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03436420 about?
NCT03436420 is a clinical study titled "Gemcabene for the Treatment of Pediatric NAFLD". This is a multicenter, prospective, open-label, Phase 2, proof of concept study to test preliminary efficacy and safety of gemcabene in children with established nonalcoholic fatty liver disease (NAFLD) incompletely treated by lifestyle changes. The hypothesis of the study is that 300 mg of gemcaben...
What is the current status of trial NCT03436420?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2018-03-29. Estimated completion is 2019-08-27.
What interventions are being tested in trial NCT03436420?
The interventions under investigation include: Gemcabene (DRUG).
Who is sponsoring clinical trial NCT03436420?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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