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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01754714 | Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group | PHASE3 | COMPLETED | 108 | — | — | Dec 1, 2012 | Sep 1, 2014 | Feb 19, 2016 | 32 | France, Germany +2 |
After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
| Arm | Type | Description |
|---|---|---|
| 1000 mg SAMe (S-adenosyl-L-methionine) | EXPERIMENTAL | - |
| 1500 mg SAMe | EXPERIMENTAL | - |
| 2000 mg SAMe | EXPERIMENTAL | - |
| No treatment | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| SAMe 1000 mg | DRUG | 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner |
| SAMe 1500 mg | DRUG | 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner |
| SAMe 2000 mg | DRUG | 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner |
Inclusion Criteria * Subjects with non-alcoholic steatohepatitis based on histology in medical history within the last 3 years * Subjects in a stable metabolic condition since histology for NASH (Non-alcoholic Steatohepatitis) Exclusion Criteria * Subjects with extrahepatic biliary obstruction * ...