At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
IMM-124E +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease
In Brief
A Phase 2 clinical trial evaluating IMM-124E and Placebo for Nonalcoholic Fatty Liver Disease (NAFLD). Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNonalcoholic Fatty Liver Disease (NAFLD)
CountriesUnited States
CollaboratorsAdvanced MR Analytics AB, Immuron Ltd.
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
Enrollment StartFeb 2017
First PostedFeb 2017
Primary CompletionOct 2019
TodayJul 2026
First PostedFeb 3, 2017
Enrollment StartFeb 1, 2017
Primary CompletionOct 23, 2019
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.4 years ago
Interventions
IMM-124Ebiological
IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.
Placeboother
Matched Placebo