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NCT04155099 · ClinicalTrials.gov registry record · Phase 2
Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy
A Phase 2 study, sponsored by Ochsner Health System.
- Terminated
- Registry status
- Phase 2
- Development phase
- 5
- Enrollment target
NCT04155099 is a Phase 2 study that was terminated before completion, run by Ochsner Health System. The registered enrollment target is 5 participants.
The verdict
NCT04155099, a Phase 2 study, was terminated before completion, sponsored by Ochsner Health System.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 5 participants
- Enrollment target
Study Summary
Individuals with cirrhosis are likely to develop overt hepatic encephalopathy for which diagnostic modalities and treatment options are limited. The purpose of this study is to determine if individuals with cirrhosis who experience hepatic encephalopathy would benefit from investigational microbiota restoration therapy due to their inherent cognitive alterations. Analysis for a correlation between changes in microbiome composition and specific blood biomarkers could allow for earlier diagnosis of HE which could then be treated earlier and with novel treatments.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL RBX7455
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-03-01 |
| Est. Completion | 2023-07-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04155099
The ClinicalTrials.gov registry entry for NCT04155099 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ochsner Health System, which has 29 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04155099 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04155099 about?
NCT04155099 is a clinical study titled "Investigational Microbiota Restoration Therapeutic for Hepatic Encephalopathy". Individuals with cirrhosis are likely to develop overt hepatic encephalopathy for which diagnostic modalities and treatment options are limited. The purpose of this study is to determine if individuals with cirrhosis who experience hepatic encephalopathy would benefit from investigational microbiota...
What is the current status of trial NCT04155099?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 5 participants. The study started on 2021-03-01. Estimated completion is 2023-07-30.
What interventions are being tested in trial NCT04155099?
The interventions under investigation include: Placebo (BIOLOGICAL), RBX7455 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04155099?
This trial is sponsored by Ochsner Health System, which has 29 total clinical trials registered on ClinicalTrials.gov.
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