Tocotrienol for End Stage Liver Disease

Overseen By Kaitlyn Depinet, FNP-C

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Chandan Sen

Must not be taking: Vitamin E

Disqualifiers: Hepatocellular carcinoma, HIV/AIDS, Hepatitis B/C, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a supplement called Tocotrienol (TCT) to determine if it can slow liver damage in individuals with end-stage liver disease (ESLD) caused by fat buildup in the liver. Participants will take either TCT or a placebo (a pill with no active ingredient) twice daily for three years. The primary goal is to assess whether TCT can prevent liver deterioration, measured by a specific liver disease score. Individuals with ESLD due to non-alcoholic liver conditions and stable liver function may be suitable for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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.

Is there any evidence suggesting that Tocotrienol (TCT) is likely to be safe for humans?

Research has shown that tocotrienol (TCT), a type of vitamin E, is generally safe for consumption. Studies have found that people tolerate TCT well when taken orally, and they have included it in their diets without major safety issues. One study found that TCT reduced the MELD score, which measures liver disease severity, in about half of the patients with advanced liver disease who used it. These studies reported no serious side effects. This suggests that TCT could be a safe option for those considering participation in a clinical trial for severe liver disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for end-stage liver disease, such as liver transplants and medications like diuretics and beta-blockers, Tocotrienol (TCT) offers a unique approach. Tocotrienol is a form of vitamin E that has potent antioxidant properties, which might help protect liver cells from damage. Researchers are excited about TCT because it targets oxidative stress, a major factor in liver disease progression, potentially offering a non-invasive and natural alternative to current treatment options.

What evidence suggests that Tocotrienol might be an effective treatment for end stage liver disease?

Research has shown that tocotrienol, a type of vitamin E, may help treat liver problems. In a study with patients waiting for liver transplants, tocotrienol reduced the severity of liver disease in half of the participants. It also decreased liver inflammation and scarring in conditions like nonalcoholic fatty liver disease. In this trial, participants will receive either a tocotrienol supplement or a placebo. These findings suggest that tocotrienol might slow liver disease progression and improve liver health. Overall, the evidence offers hope for its potential to manage severe liver disease. ^{3 5 6 7 8}

Who Is on the Research Team?

Raj Vuppalanchi, MD

Principal Investigator

Indiana Unviersity School of Medicine

Chandan K Sen, Ph.D

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-14 days

Initial visit, Randomization visit

Treatment

Participants receive either 800mg TCT or placebo capsules twice daily for 3 years

3 years

Visits at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 18 months, 2 years, and 3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Tocotrienol (TCT)

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Chandan Sen

Lead Sponsor

Trials

3

Recruited

380+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Malaysia Palm Oil Board

Collaborator

Trials

39

Recruited

3,100+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3278267/

Oral Tocotrienols Are Transported to Human Tissues and ... In prospective liver transplantation patients, oral TE lowered the model for end-stage liver disease (MELD) score in 50% of patients ...

2. withpower.com withpower.com/trial/phase-3-liver-diseases-10-2019-7d8aa

Tocotrienol for End Stage Liver Disease · Info for Participants Research shows that tocotrienol, a form of vitamin E, can reduce liver inflammation and fibrosis (scarring) in conditions like nonalcoholic fatty liver disease ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02581085/tocotrienol-against-the-progression-of-end-stage-liver-disease

Tocotrienol Against the Progression of End Stage Liver ... 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 ...

4. wexnermedical.osu.edu wexnermedical.osu.edu/mediaroom/pressreleaselisting/vitamin-e-tocotrienol-supplement-delays-progression-of-advanced-liver-disease

Vitamin E Tocotrienol Supplement Delays Progression of ... Oral administration of tocotrienol also lowered the model for end stage liver disease (MELD) score in 50 percent of the patients who received TE ...

5. research-studies.allinforhealth.info research-studies.allinforhealth.info/us/en/listing/10212/tocotrienol-against-the-progression/

Tocotrienol Against the Progression of End Stage Liver Disease The purpose of this study is to see if oral tocotrienol (TCT) will significantly reduce the rise in Model for End Stage Liver Disease (MELD) ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9965814/

Tocotrienol in the Management of Nonalcoholic Fatty Liver ... If left untreated, NASH will progress to cirrhosis and end-stage liver disease requiring liver transplantation, or to hepatocellular carcinoma.

7. clinicaltrial.be clinicaltrial.be/en/details/73806?per_page=20&only_recruiting=0&only_eligible=0

Tocotrienol Against the Progression of End Stage Liver Di... Tocotrienol (TCT) is a natural vitamin E supplement with a long history of safe dietary consumption. Prior studies with Vitamin E have shown beneficial ...

8. ctv.veeva.com ctv.veeva.com/study/tocotrienol-against-the-progression-of-end-stage-liver-disease

Tocotrienol Against the Progression of End Stage Liver Disease Tocotrienol (TCT) is a natural vitamin E supplement with a long history of safe dietary consumption. ... Data sourced from clinicaltrials.gov.