Tocotrienol Against the Progression of End Stage Liver Disease

• Status: Recruiting
• Trial end date: 2028-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Malaysia Palm Oil Board
• Treatments: Tocopherols; Tocotrienols; Vitamin E

Criteria

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 15 over the past 6 months (+/- 1 month) prior to enrollment

• 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:

• Rapid deterioration of liver function, over the past 6 months (+/- 1 month) prior to enrollment per study physician determination

• Hepatocellular carcinoma

• Positive HIV/ AIDS, or other chronic immunodeficiency

• Concurrent hepatitis A or B infection

• Current drug and/or alcohol abuse (per treating physician)

• Bacterial infection at time of enrollment

• Daily use of dedicated vitamin E supplementation within the 12 months prior to study participation

• Platelets <25,000 cells/µL, neutrophils <1000 cells/µL, hemoglobin <8g/dL, total bilirubin >3mg/dL, serum creatinine >2.0mg/dL

• 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

• Patients receiving medications known to treat Hepatitis C; patients who begin taking these medications during the course of study participation will be dropped.