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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00573313 | Effects of SAMe in Patients With Alcoholic Liver Disease | PHASE3 | COMPLETED | 94 | — | — | Sep 1, 2005 | Sep 1, 2009 | May 30, 2017 | 1 | United States |
Biochemical values for liver function tests and histopathology scores were obtained at week 0 and 24 of the treatment trial, and changes in each were recorded. Here are reported changes in aspartate transaminase (AST) as representative of all changes. Since only baseline values were obtained in the Healthy and Lifestyle counseling groups, there are no recorded changes in these two groups.
| Arm | Type | Description |
|---|---|---|
| S-adenosylmethionine (SAMe) | EXPERIMENTAL | Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks |
| Sugar pill | PLACEBO_COMPARATOR | ALD subjects receiving Placebo three times daily for 24 weeks. |
| Name | Type | Description |
|---|---|---|
| S-adenosylmethionine | DRUG | Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks. |
| Placebo | DRUG | Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks. |
Inclusion Criteria * ALD) a history of chronic alcoholism according to established AUDIT and WHO criteria with the presence of clinical and laboratory features of established liver disease. Also, willingness to undergo liver biopsies at start and completion of the study, and to comply with study me...