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NCT03042767 · ClinicalTrials.gov registry record · Phase 2
Anti-LPS Antibody Treatment for Pediatric NAFLD
A Phase 2 study of Non-Alcoholic Fatty Liver Disease (NAFLD), sponsored by Miriam Vos, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT03042767: Completed Phase 2 study of Non-Alcoholic Fatty Liver Disease (NAFLD), sponsored by Miriam Vos, MD.
NCT03042767 is a Phase 2 study of Non-Alcoholic Fatty Liver Disease (NAFLD) that has completed, run by Miriam Vos, MD. The registered enrollment target is 40 participants, below the 87-participant average among 9 other Non-Alcoholic Fatty Liver Disease (NAFLD) trials with a reported enrollment target (54% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03042767, a Phase 2 study of Non-Alcoholic Fatty Liver Disease (NAFLD), has completed, sponsored by Miriam Vos, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT). Specifically, investigators will measure percent change in ALT from Week 0 to Week 12 in treatment compared to placebo.
Primary Outcome
Percent change in ALT level from baseline to end of treatment.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL IMM-124E
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2017-02-01 |
| Est. Completion | 2019-10-23 |
| Phase | Phase 2 |
What the finished NCT03042767 record still lists
NCT03042767 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 87-participant average among 9 other Non-Alcoholic Fatty Liver Disease (NAFLD) trials with a reported enrollment target (54% lower).
The record links to 1 condition, with Non-Alcoholic Fatty Liver Disease (NAFLD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03042767 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT03042767 about?
NCT03042767 is a clinical study titled "Anti-LPS Antibody Treatment for Pediatric NAFLD". The main objective of this pilot study is to evaluate whether 12 weeks of IMM-124E in children with nonalcoholic fatty liver disease (NAFLD) in combination with standard of care treatment will decrease inflammation in the liver as measured by alanine transaminase (ALT). Specifically, investigators w...
What is the current status of trial NCT03042767?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2017-02-01. Estimated completion is 2019-10-23.
What conditions does trial NCT03042767 study?
This clinical trial studies the following conditions: Non-Alcoholic Fatty Liver Disease (NAFLD).
What interventions are being tested in trial NCT03042767?
The interventions under investigation include: Placebo (OTHER), IMM-124E (BIOLOGICAL).
Who is sponsoring clinical trial NCT03042767?
This trial is sponsored by Miriam Vos, MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03042767 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Non-Alcoholic Fatty Liver Disease (NAFLD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03042767's enrollment target sits among peer trials
40 5th of 9 higher than 4 of 9 other Non-Alcoholic Fatty Liver Disease (NAFLD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Alcoholic Fatty Liver Disease (NAFLD) 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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