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Adjusted LOA
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S-adenosylmethionine · 1 trial · 1 indication
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...
S-adenosylmethionine (SAMe) is an investigational small molecule being studied for the treatment of alcoholic liver disease. It is in Phase 3 clinical development, though the Phase 3 trial has been completed. The drug is being developed by Abbott Laboratories.
Abbott Laboratories (NYSE: ABT) is developing S-adenosylmethionine for alcoholic liver disease. The drug is currently in Phase 3 clinical development, with one completed Phase 3 trial. It is an investigational small molecule and has not been approved by the FDA.
S-adenosylmethionine is in Phase 3 clinical development for alcoholic liver disease. The Phase 3 trial has been completed, and the drug remains investigational. It is not FDA approved. The trial enrolled 94 participants and was randomized, double-blind, and placebo-controlled.
S-adenosylmethionine has one completed Phase 3 clinical trial, NCT00573313, titled "Effects of SAMe in Patients With Alcoholic Liver Disease." The trial enrolled 94 participants in the United States, was randomized, double-blind, and placebo-controlled, and included healthy volunteers.
Yes, S-adenosylmethionine is also known as SAMe. The completed Phase 3 trial NCT00573313, "Effects of SAMe in Patients With Alcoholic Liver Disease," used the abbreviation SAMe in its title. The drug is being developed by Abbott Laboratories for alcoholic liver disease.