Tocotrienol Against the Progression of End Stage Liver Disease

Korábbi kezelés

• Rapid deterioration of liver function, as defined by an increase in MELD score ≥25% over the past 60 days prior to enrollment
• Concurrent hepatitis B or C infection
• Current drug and/or alcohol abuse (per treating physician)
• Daily use of dedicated vitamin E supplementation (greater than 100 IU per day) within the 3 months prior to study participation
• Concurrent enrollment in another interventional clinical trial
• Any weight reduction surgery in the preceding 2 years prior to screening or planned surgery during the study

Más betegség

• Positive HIV/AIDS, or other chronic immunodeficiency
• Bacterial infection at time of enrollment
• History of liver transplantation
• Current or history of HCC
• 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

Laborértékek

• Platelets <35,000 cells/µL, neutrophils <1000 cells/µL, hemoglobin <10g/dL, total bilirubin >3mg/dL, serum creatinine >2.0mg/dL
• ALT >250 U/L
• AST > 250 U/L
• Hemoglobin A1C ≥ 9.5 %

Egyéb

• Hepatocellular carcinoma
• 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

• 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