| Trial ID: | L0559 |
| Source ID: | NCT03042767
|
| Associated Drug: |
IMM-124E
|
| Title: |
Anti-LPS Antibody in Pediatric Nonalcoholic Fatty Liver Disease
|
| Acronym: |
--
|
| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Fatty Liver Disease (NAFLD)
|
| Interventions: |
Biological: IMM-124E;Other: Placebo
|
| Outcome Measures: |
Percent Change in Alanine Aminotransferase (ALT) LevelChange in Fasting Glucose Level;Change in Fasting Insulin Level;Change in Hemoglobin A1C Level;Change in Adipose Tissue Insulin Resistance (Adipo-IR);Change in Triglyceride/HDL (TG/HDL) Ratio;Change in Blood Glucose Level;Change in Insulin Levels;Change in Body Mass Index (BMI) Z-Score;Change in Visceral Adiposity;Change in Hepatic Fat Percent;Change in Waist Circumference;Change in PROMIS Fatigue Questionnaire Score;Change in PROMIS Depression Questionnaire Score;Change in PROMIS Anxiety Questionnaire Score;Composite Metabolic Improvement
|
| Sponsor/Collaborators: |
Miriam Vos, MD
|
| Gender: |
All
|
| Age: |
6 Years19 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
40
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
| Start Date: |
02/02/2017
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
12 December 2020
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT03042767
|
