Overview

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.