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Vitamin E Derivative

Tocotrienol for End Stage Liver Disease

Phase 2
Waitlist Available
Led By Raj Vuppalanchi, M.D.
Research Sponsored by Chandan Sen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ESLD patients with clinically-diagnosed NAFLD or NASH
Absence of any other possible cause for liver dysfunction
Must not have
Rapid deterioration of liver function, as defined by an increase in MELD score ≥25% over the past 60 days prior to enrollment
Hepatocellular carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years

Summary

This trial is to see if a previous trial's results were accurate- that Tocotrienol (TCT) could help end stage liver disease / cirrhosis patients by taking 2 capsules of it (200mg) or placebo twice a day for 3 years.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed here, participants may experience unexpected health issues related to taking Tocotrienol over an extended period. Regular monitoring will help identify any potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have end-stage liver disease due to fatty liver.
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My liver issues are not caused by anything else.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver function has worsened quickly, with a significant increase in my MELD score recently.
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I have liver cancer.
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I have HIV/AIDS or another long-term immune system problem.
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I have hepatitis B or C.
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I have a bacterial infection currently.
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I have been taking more than 100 IU of vitamin E daily for the last 3 months.
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I do not have other major health issues reducing my life expectancy to under 3 years.
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I have or had liver cancer.
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I have had a liver transplant.
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I am not pregnant, breastfeeding, nor plan to become pregnant in the next 3 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect of Oral tocotrienols (TCT) on Model for End-Stage Liver Disease (MELD) score.
Secondary study objectives
Adverse events
Change in ALT Alanine transaminase
Change in Child-Pugh Score
+7 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Tocotrienol supplementActive Control1 Intervention
Subjects will take (2) 200 mg TCT capsules following AM meal, (2) 200 mg TCT following PM meal
Group II: Placebo VehiclePlacebo Group1 Intervention
Subjects will take 2 placebo capsules following AM meal, 2 placebo capsules following PM capsules

Find a Location

Who is running the clinical trial?

Chandan SenLead Sponsor
2 Previous Clinical Trials
310 Total Patients Enrolled
Indiana UniversityOTHER
1,039 Previous Clinical Trials
1,218,988 Total Patients Enrolled
Malaysia Palm Oil BoardOTHER_GOV
38 Previous Clinical Trials
3,070 Total Patients Enrolled

Media Library

Tocotrienol (TCT) (Vitamin E Derivative) Clinical Trial Eligibility Overview. Trial Name: NCT02581085 — Phase 2
Liver Disease Research Study Groups: Placebo Vehicle, Tocotrienol supplement
Liver Disease Clinical Trial 2023: Tocotrienol (TCT) Highlights & Side Effects. Trial Name: NCT02581085 — Phase 2
Tocotrienol (TCT) (Vitamin E Derivative) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02581085 — Phase 2
~31 spots leftby Dec 2028
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