Tocotrienol for End Stage Liver Disease
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot participate if you have been taking more than 100 IU of vitamin E daily in the past 3 months.
What data supports the effectiveness of the drug Tocotrienol for End Stage Liver Disease?
Is tocotrienol safe for humans?
How is tocotrienol different from other treatments for end-stage liver disease?
Tocotrienol is unique because it is a form of vitamin E that can be taken orally and has been shown to lower the model for end-stage liver disease (MELD) score in some patients, which is not commonly achieved by other treatments. It also has potent anti-inflammatory and antioxidant properties that may help protect the liver.12467
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.
Research Team
Raj Vuppalanchi, MD
Principal Investigator
Indiana Unviersity School of Medicine
Chandan K Sen, Ph.D
Principal Investigator
University of Pittsburgh
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either 800mg TCT or placebo capsules twice daily for 3 years
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Placebo
- Tocotrienol (TCT)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Chandan Sen
Lead Sponsor
Indiana University
Collaborator
Malaysia Palm Oil Board
Collaborator