Tocotrienol Against the Progression of End Stage Liver Disease

1807361301

The purpose of this Phase 2 trial is to validate the outcome observed in a previous trial that oral Tocotrienol (TCT) attenuates the rise in MELD score over time in patients with end stage liver disease / cirrhosis. The study is double blind and participants will be randomized to take 2 capsules of TCT (200mg) or placebo twice a day for 3 years.

2019-11-01

2028-12-31

2028-12-31

Recruiting

Early phase I

70

Inclusion Criteria: * Age 18 years of above, male or female * ESLD patients with clinically- diagnosed NAFLD or NASH * Absence of any other possible cause for liver dysfunction * Stable MELD score of at least 8, but no greater than 17 with \<25% change in MELD over the past 60 days prior to enrollment (\*Total number of patients with MELD of 8-9 or MELD of 16-17 cannot exceed 40% of cohort) * Able to speak and understand English * Willing and able to provide informed consent * Willing and able to return for regularly scheduled research study visits \& comply with study requirements Exclusion Criteria: 1. Rapid deterioration of liver function, as defined by an increase in MELD score ≥25% over the past 60 days prior to enrollment 2. Hepatocellular carcinoma 3. Positive HIV/AIDS, or other chronic immunodeficiency 4. Concurrent hepatitis B or C infection 5. Current drug and/or alcohol abuse (per treating physician) 6. Bacterial infection at time of enrollment 7. Daily use of dedicated vitamin E supplementation (greater than 100 IU per day) within the 3 months prior to study participation 8. Platelets \<35,000 cells/µL, neutrophils \<1000 cells/µL, hemoglobin \<10g/dL, total bilirubin \>3mg/dL, serum creatinine \>2.0mg/dL 9. Women who are pregnant, breastfeeding, or plan to become pregnant during course of study participation (36 months) 10. Other significant comorbidities which limit the subject's life expectancy to less than 36 months 11. Concurrent enrollment in another interventional clinical trial 12. ALT \>250 U/L 13. AST \> 250 U/L 14. Hemoglobin A1C ≥ 9.5 % 15. History of liver transplantation 16. Current or history of HCC 17. Any weight reduction surgery in the preceding 2 years prior to screening or planned surgery during the study 18. Malignancy within 5 years of screening with the exception of a Adequately treated carcinoma in situ of the cervix b. Adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer

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2023-07-20