Tocotrienol for End Stage Liver Disease

Recruiting in Palo Alto (17 mi)

Overseen by Raj Vuppalanchi, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Chandan Sen

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Adults with end stage liver disease or cirrhosis, specifically from non-alcoholic fatty liver disease (NAFLD) or NASH, who have a stable MELD score between 8 and 17. Participants must not have other causes for liver dysfunction, no hepatitis B/C or HIV/AIDS, no recent rapid deterioration of liver function, and cannot be pregnant or planning pregnancy.

Inclusion Criteria

Willing and able to provide informed consent

I can attend all required study visits and follow the study rules.

I have end-stage liver disease due to fatty liver.

Exclusion Criteria

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

My liver function has worsened quickly, with a significant increase in my MELD score recently.

I have liver cancer.

Participant Groups

The trial is testing if Tocotrienol (TCT), taken as two capsules twice daily for three years, can slow down the worsening of the MELD score in patients with advanced liver disease compared to a placebo. The study is double-blind and randomized.

Group I: Tocotrienol supplement Active Control 1 Intervention

Subjects will take (2) 200 mg TCT capsules following AM meal, (2) 200 mg TCT following PM meal

Group II: Placebo Vehicle Placebo Group 1 Intervention

Subjects will take 2 placebo capsules following AM meal, 2 placebo capsules following PM capsules

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

IU Health Unviersity Hospital Indianapolis, IN

Who Is Running the Clinical Trial?

Chandan Sen Lead Sponsor

Indiana University Collaborator

Malaysia Palm Oil Board Collaborator

References