Phase 3
Completed N=173
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
Source: ClinicalTrials.gov NCT00063635 ↗Enrolled (actual)
173
Serious AEs
15.6%
Results posted
Sep 2012
Primary outcomePrimary: Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L — 9; 15; 10 participants — p=0.26
Summary
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L |
9; 15; 10 | 0.26 |
| SECONDARY Change in Serum Aspartate Aminotransferase (AST) |
-21.5; -22.8; -20.4 | 0.32 |
| SECONDARY Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment |
-1.1; -1.8; -0.7 | 0.02 sig |
| SECONDARY Number of Participants With Improvement in Liver Fibrosis Score |
22; 18; 19 | 0.71 |
| SECONDARY Number of Participants With Improvement in Steatosis Score |
26; 27; 19 | 0.18 |
| SECONDARY Number of Participants With Improvement in Lobular Inflammation Score |
23; 22; 20 | 0.89 |
| SECONDARY Number of Participants With Improvement in Ballooning Degradation Score |
22; 22; 10 | 0.02 sig |
| SECONDARY Change in Body Mass Index |
1.3; 2.1; 1.9 | 0.77 |
| SECONDARY Change in Serum Vitamin E Levels |
-0.5; 9.4; -0.9 | <0.001 sig |
| SECONDARY Change in Quality of Life (QOL) Scores- Physical Health |
5.4; 7.6; 5.4 | 0.08 |
| SECONDARY Change in QOL- Psychosocial Health |
4.0; 6.0; 5.6 | 0.15 |
Eligibility Criteria
- Age 8-17 years at first screening visit
- Histologic evidence of Nonalcoholic Fatty Liver Disease (NAFLD) - biopsy cannot be older than 6 months as of randomization
- ALT level >60 U/L at time of screening and on one previous occasion determined at least one month but no greater than 6 months prior to screening ALT
- Consent
Data sourced from ClinicalTrials.gov (NCT00063635). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.