Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03042767 | Anti-LPS Antibody Treatment for Pediatric NAFLD | PHASE2 | COMPLETED | 40 | — | — | Feb 1, 2017 | Oct 23, 2019 | May 24, 2021 | 1 | United States |
Percent change in ALT level from baseline to end of treatment.
| Arm | Type | Description |
|---|---|---|
| IMM-124E Group | EXPERIMENTAL | Participants with nonalcoholic fatty liver disease (NAFLD) will receive 600mg of IMM-124E powder three times daily for twelve weeks. |
| Placebo Group | PLACEBO_COMPARATOR | Participants with nonalcoholic fatty liver disease (NAFLD) will receive placebo powder three times daily for twelve weeks. |
| Name | Type | Description |
|---|---|---|
| IMM-124E | BIOLOGICAL | IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring. |
| Placebo | OTHER | Matched Placebo |
Inclusion Criteria: * Nonalcoholic fatty liver disease (NAFLD) diagnosis confirmed by liver biopsy or MRI * ALT ≥ 2 x ULN at screening (girls ≥ 46, boys ≥ 54) * Written informed parent consent and child assent * Willingness to take IMM-124E or placebo powder 3 x daily for 12 weeks * At least 2 mont...