Tocotrienol Against the Progression of End Stage Liver Disease
Study on the Effects of Investigational Medication on Liver Disease Progression
Brief description of study.
The purpose of this study is to see if oral tocotrienol (TCT) will significantly reduce the rise in Model for End Stage Liver Disease (MELD) score over time in patients with Nonalcoholic Steatohepatits (NASH).
Detailed description of study
Vitamin E is a generic term for tocotrienols (TCT). Natural vitamin E, TCT is found in the seed of a number of important cereal grains including wheat, barley and rice. The United States Food and Drug Administration (FDA) has recently determined that GRAS (Generally Recognized As Safe) status for TCT for inclusion in food products. The purpose of this study is to see if oral tocotrienol (TCT) will significantly reduce the rise in Model for End Stage Liver Disease (MELD) score over time in patients with Nonalcoholic Steatohepatits (NASH). MELD is used as a measure of mortality risk in patients with end-stage liver disease.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Nonalcoholic Steatohepatitis (NASH),Liver Disease
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Age: 18 years - 100 years
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Gender: All
Inclusion Criteria
ESLD patients with biopsy-diagnosed NASH: : Liver biopsy within 12 months of screening consistent with NASH cirrhosis (evidenced by F4 fibrosis with or without the presence of steatohepatitis according to the NASH CRN classification, in the opinion of the central reader)
Absence of any other possible cause for liver dysfunction
Able to speak and understand English
Exclusion Criteria
Rapid deterioration of liver function
Hepatocellular carcinoma
Positive HIV/ AIDS, or other chronic immunodeficiency
Concurrent hepatitis infection
Bacterial infection at time of enrollment
Daily use of dedicated vitamin E supplementation within the 12 months prior to study participation
Women who are pregnant, breastfeeding, or plan to become pregnant during course of study participation (36 months)
Other significant comorbidities which limit the subject’s life expectancy to less than 36 months
Concurrent enrollment in another clinical trial
Use of medication known to cause hepatic injury within 3 months from screening/enrollment
History of liver transplantation
Current or history of HCC
HIV infection
Any weight reduction surgery in the preceding 2 years prior to screening or planned surgery during the study
Chronic HCV infection. Subjects cure of HCV infection less than 5 years prior to the screening visit are not eligible
Malignancy within 5 years of screening with the exception of
-Adequately treated carcinoma in situ of the cervix
-Adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer
This study investigates the impact of an investigational medication, specifically oral tocotrienol (TCT), on patients with Nonalcoholic Steatohepatitis (NASH) and its potential to reduce the Model for End Stage Liver Disease (MELD) score over time. NASH is a liver condition characterized by inflammation and damage caused by a buildup of fat in the liver. The MELD score is a measure used to assess the severity of chronic liver disease and predict mortality risk.
Participants in this study will receive either the investigational medication or a placebo, which is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will monitor changes in the MELD score to determine the effectiveness of the investigational medication in slowing down liver disease progression.
- Who can participate: Adults with end-stage liver disease due to NASH, confirmed by a liver biopsy within the past year, are eligible. Participants must not have other causes of liver dysfunction and should be able to communicate in English.
- Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo. The placebo is an inactive substance that resembles the investigational medication but contains no active ingredients.
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