End Stage Liver DiseasePhase 2NCT02581085
Tocotrienol Against the Progression of End Stage Liver Disease
A Phase 2 study testing Tocotrienol (TCT) in people with End Stage Liver Disease and NASH - Nonalcoholic Steatohepatitis, run by Chandan Sen at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Liver Disease, NASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver Disease
- What is being tested?
- Tocotrienol (TCT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 16 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 17 with <25% change in MELD over the past 60 days prior to enrollment (*Total number of patients with MELD of 8-9 or MELD of 16-17 cannot exceed 40% of cohort)
- 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
Who cannot join
- Rapid deterioration of liver function, as defined by an increase in MELD score ≥25% over the past 60 days prior to enrollment
- Hepatocellular carcinoma
- Positive HIV/AIDS, or other chronic immunodeficiency
- Concurrent hepatitis B or C infection
- Current drug and/or alcohol abuse (per treating physician)
- Bacterial infection at time of enrollment
Show all 18Show fewer
- Daily use of dedicated vitamin E supplementation (greater than 100 IU per day) within the 3 months prior to study participation
- Platelets <35,000 cells/µL, neutrophils <1000 cells/µL, hemoglobin <10g/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
- Concurrent enrollment in another interventional clinical trial
- ALT >250 U/L
- AST > 250 U/L
- Hemoglobin A1C ≥ 9.5 %
- History of liver transplantation
- Current or history of HCC
- Any weight reduction surgery in the preceding 2 years prior to screening or planned surgery during the study
- Malignancy within 5 years of screening with the exception of a Adequately treated carcinoma in situ of the cervix b. Adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Unviersity Hospital
Indianapolis, Indiana, 46202
About this study
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.
Read the detailed description
Tocotrienol (TCT) is a natural vitamin E supplement with a long history of safe dietary consumption. Prior studies with Vitamin E have shown beneficial effects in patients with non-alcoholic fatty liver disease and cirrhosis. The primary purpose of this Phase 2 trial is to validate the outcome observed in an earlier trial that oral TCT attenuates the rise in MELD (Model For End-Stage Liver Disease) score over time in patients with cirrhosis. Outcomes of this trail will direct the design of a future larger multi-center trial.
Study participation will last 3 years. Subjects will be seen for an initial visit, at which consent will be obtained and baseline labs drawn, followed by a Randomization visit 2-14 days later after MELD criteria have been confirmed. If the acceptable labs have not been drawn per standard of care to calculate a MELD score within 90 days before the initial visit, the subject will complete the initial visit as planned, but will then return for a repeat lab draw 60 days later to confirm MELD criteria for eligibility before continuing to the randomization visit.
Enrollment occurs when a subject meets all criteria and is randomized into one of the treatment groups. Subjects will then be seen in the research office by research personnel at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 18 months, 2 years, and 3 years. Subject compliance with supplements will be closely followed, as compliance is critical for accurate data. Given the small sample size, subjects who are less than 75% compliant at two consecutive study visits will be discontinued from the study. Subjects will be discontinued if their MELD score increases by more than 25% between 2 consecutive visits or if they receive an organ transplant. Subjects will be declared lost to follow-up (LTFU) if a study visit is unable to be scheduled and completed after 4 documented attempts to contact a subject with no response. In this circumstance, a certified letter will be mailed to the subject's last known address; if no response is received, the subject is LTFU. All subjects discontinued or LTFU before the end of 1 year of study participation will be replaced (see protocol to review study visit activities that will occur). At the Randomization Visit, enrolled subjects will be randomized into one of two treatment groups in a 1:1 manner. Group 1: Placebo vehicle; (2) placebo capsules following AM meal, (2) placebo capsules following PM meal Group 2: 800mg TCT; (2) 200mg TCT capsules following AM meal, (2) 200mg TCT capsules following PM meal.
- Conditions
- End Stage Liver Disease, NASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver Disease
- Being tested
- Tocotrienol (TCT), Placebo
- Keywords
- Tocotrienol, Vitamin E
- Medical subject headings
- End Stage Liver Disease, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tocotrienol (TCT)Drug
TCT is a natural vitamin E supplement with a long history of safe dietary consumption in humans. The objective of the current trial is to validate the outcome observed in an earlier trial that oral TCT attenuates the rise in MELD score over time in patients with end stage liver disease/cirrhosis.
PlaceboOther
Also called vehicle
Control study capsule that includes no study product (Vitamin E - Tocotrienol)
| Study group | Role | What they receive |
|---|---|---|
| Placebo Vehicle | Placebo comparator | Subjects will take 2 placebo capsules following AM meal, 2 placebo capsules following PM capsules Receives: Other: Placebo |
| Tocotrienol supplement | Active comparator | Subjects will take (2) 200 mg TCT capsules following AM meal, (2) 200 mg TCT following PM meal Receives: Drug: Tocotrienol (TCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Oral tocotrienols (TCT) on Model for End-Stage Liver Disease (MELD) score.
Lab tests to calculate MELD score will be taken at baseline study visit and the last study visit ( Study visit 17 - 3 years) to see if Oral TCT will significantly attenuate the rise in MELD score over time in patients with End Stage Liver Disease / Cirrhosis
Measured: 3 years
Secondary outcomes (11)
Composite clinical endpoint
all-cause mortality, liver transplant, new onset ascites, hepatic encephalopathy, gastroesophageal variceal hemorrhage, and confirmed increase of MELD score by 3 points due to liver disease.
Measured: 3 yrs
Change in Child-Pugh Score
change in Child-Pugh Score
Measured: 3 years
Change in ALT Alanine transaminase
Change in ALT (Alanine transaminase)
Measured: 3 years
Events of hepatic decompensation
Events of hepatic decompensation
Measured: 3 yrs
New onset ascites requiring treatment with or without paracentesis
New onset ascites requiring treatment with or without paracentesis
Measured: 3 yrs
GI bleed attributed to variceal bleeding
GI bleed attributed to variceal bleeding, requires evaluation by an endoscopy
Measured: 3 yrs
Hepatic encephalopathy requiring treatment
Hepatic encephalopathy requiring treatment, Grade 2 or above according to West Haven Criteria
Measured: 3 yrs
Need for Liver transplant
Need for liver transplant
Measured: 3 yrs
Death
did death occur
Measured: 3 yrs
Liver fibrosis
Liver fibrosis as measured by change in LSM by vibration-controlled transient elastography
Measured: 3 yrs
Adverse events
Did any AEs occur
Measured: 3 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start1 Nov 2019
- Primary completion16 Dec 2025
- Study completion16 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chandan Sen
- Sponsor type
- University, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Indiana University
- Responsible party
- Sponsor-investigator, Chandan Sen, University of Pittsburgh
- Investigators
- Chandan K Sen, Ph.D, Study chair, University of PittsburghRaj Vuppalanchi, M.D., Principal investigator, Indiana Unviersity School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02581085
- Sponsor's protocol ID
- 1807361301
- Other IDs
- 136352
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2015
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.
PubMed 22298568Chitturi S, Abeygunasekera S, Farrell GC, Holmes-Walker J, Hui JM, Fung C, Karim R, Lin R, Samarasinghe D, Liddle C, Weltman M, George J. NASH and insulin resistance: Insulin hypersecretion and specific association with the insulin resistance syndrome. Hepatology. 2002 Feb;35(2):373-9. doi: 10.1053/jhep.2002.30692.
PubMed 11826411Ray K. NAFLD-the next global epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):621. doi: 10.1038/nrgastro.2013.197. No abstract available.
PubMed 24185985Schwenger KJ, Allard JP. Clinical approaches to non-alcoholic fatty liver disease. World J Gastroenterol. 2014 Feb 21;20(7):1712-23. doi: 10.3748/wjg.v20.i7.1712.
PubMed 24587650Schwimmer JB, Behling C, Newbury R, Deutsch R, Nievergelt C, Schork NJ, Lavine JE. Histopathology of pediatric nonalcoholic fatty liver disease. Hepatology. 2005 Sep;42(3):641-9. doi: 10.1002/hep.20842.
PubMed 16116629Review Team; LaBrecque DR, Abbas Z, Anania F, Ferenci P, Khan AG, Goh KL, Hamid SS, Isakov V, Lizarzabal M, Penaranda MM, Ramos JF, Sarin S, Stimac D, Thomson AB, Umar M, Krabshuis J, LeMair A; World Gastroenterology Organisation. World Gastroenterology Organisation global guidelines: Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. J Clin Gastroenterol. 2014 Jul;48(6):467-73. doi: 10.1097/MCG.0000000000000116. No abstract available.
PubMed 24921212Khanna S, Patel V, Rink C, Roy S, Sen CK. Delivery of orally supplemented alpha-tocotrienol to vital organs of rats and tocopherol-transport protein deficient mice. Free Radic Biol Med. 2005 Nov 15;39(10):1310-9. doi: 10.1016/j.freeradbiomed.2005.06.013.
PubMed 16257640Khanna S, Rink C, Ghoorkhanian R, Gnyawali S, Heigel M, Wijesinghe DS, Chalfant CE, Chan YC, Banerjee J, Huang Y, Roy S, Sen CK. Loss of miR-29b following acute ischemic stroke contributes to neural cell death and infarct size. J Cereb Blood Flow Metab. 2013 Aug;33(8):1197-206. doi: 10.1038/jcbfm.2013.68. Epub 2013 May 1.
PubMed 23632968Khanna S, Roy S, Slivka A, Craft TK, Chaki S, Rink C, Notestine MA, DeVries AC, Parinandi NL, Sen CK. Neuroprotective properties of the natural vitamin E alpha-tocotrienol. Stroke. 2005 Oct;36(10):2258-64. doi: 10.1161/01.STR.0000181082.70763.22. Epub 2005 Sep 15.
PubMed 16166580Park HA, Kubicki N, Gnyawali S, Chan YC, Roy S, Khanna S, Sen CK. Natural vitamin E alpha-tocotrienol protects against ischemic stroke by induction of multidrug resistance-associated protein 1. Stroke. 2011 Aug;42(8):2308-14. doi: 10.1161/STROKEAHA.110.608547. Epub 2011 Jun 30.
PubMed 21719775Patel V, Khanna S, Roy S, Ezziddin O, Sen CK. Natural vitamin E alpha-tocotrienol: retention in vital organs in response to long-term oral supplementation and withdrawal. Free Radic Res. 2006 Jul;40(7):763-71. doi: 10.1080/10715760600672491.
PubMed 16984003Rink C, Christoforidis G, Khanna S, Peterson L, Patel Y, Khanna S, Abduljalil A, Irfanoglu O, Machiraju R, Bergdall VK, Sen CK. Tocotrienol vitamin E protects against preclinical canine ischemic stroke by inducing arteriogenesis. J Cereb Blood Flow Metab. 2011 Nov;31(11):2218-30. doi: 10.1038/jcbfm.2011.85. Epub 2011 Jun 15.
PubMed 21673716Gopalan Y, Shuaib IL, Magosso E, Ansari MA, Abu Bakar MR, Wong JW, Khan NA, Liong WC, Sundram K, Ng BH, Karuthan C, Yuen KH. Clinical investigation of the protective effects of palm vitamin E tocotrienols on brain white matter. Stroke. 2014 May;45(5):1422-8. doi: 10.1161/STROKEAHA.113.004449. Epub 2014 Apr 3.
PubMed 24699052Khosla P, Patel V, Whinter JM, Khanna S, Rakhkovskaya M, Roy S, Sen CK. Postprandial levels of the natural vitamin E tocotrienol in human circulation. Antioxid Redox Signal. 2006 May-Jun;8(5-6):1059-68. doi: 10.1089/ars.2006.8.1059.
PubMed 16771695Mahipal A, Klapman J, Vignesh S, Yang CS, Neuger A, Chen DT, Malafa MP. Pharmacokinetics and safety of vitamin E delta-tocotrienol after single and multiple doses in healthy subjects with measurement of vitamin E metabolites. Cancer Chemother Pharmacol. 2016 Jul;78(1):157-65. doi: 10.1007/s00280-016-3048-0. Epub 2016 Jun 8.
PubMed 27278668
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tocotrienol Against the Progression of End Stage Liver Disease
- ClinicalTrials.gov ID
- NCT02581085
- Acronym / sponsor ID
- 1807361301
- Conditions
- End Stage Liver Disease, NASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver Disease
- Keywords
- Tocotrienol, Vitamin E
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Chandan SenUniversity, hospital or other
- Collaborators
- Malaysia Palm Oil Board, Indiana University
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 16 Dec 2025 (actual)
- Study completion
- 16 Dec 2025 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Tocotrienol (TCT) is a natural vitamin E supplement with a long history of safe dietary consumption. Prior studies with Vitamin E have shown beneficial effects in patients with non-alcoholic fatty liver disease and cirrhosis. The primary purpose of this Phase 2 trial is to validate the outcome observed in an earlier trial that oral TCT attenuates the rise in MELD (Model For End-Stage Liver Disease) score over time in patients with cirrhosis. Outcomes of this trail will direct the design of a future larger multi-center trial.
Study participation will last 3 years. Subjects will be seen for an initial visit, at which consent will be obtained and baseline labs drawn, followed by a Randomization visit 2-14 days later after MELD criteria have been confirmed. If the acceptable labs have not been drawn per standard of care to calculate a MELD score within 90 days before the initial visit, the subject will complete the initial visit as planned, but will then return for a repeat lab draw 60 days later to confirm MELD criteria for eligibility before continuing to the randomization visit.
Enrollment occurs when a subject meets all criteria and is randomized into one of the treatment groups. Subjects will then be seen in the research office by research personnel at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, 1 year, 18 months, 2 years, and 3 years. Subject compliance with supplements will be closely followed, as compliance is critical for accurate data. Given the small sample size, subjects who are less than 75% compliant at two consecutive study visits will be discontinued from the study. Subjects will be discontinued if their MELD score increases by more than 25% between 2 consecutive visits or if they receive an organ transplant. Subjects will be declared lost to follow-up (LTFU) if a study visit is unable to be scheduled and completed after 4 documented attempts to contact a subject with no response. In this circumstance, a certified letter will be mailed to the subject's last known address; if no response is received, the subject is LTFU. All subjects discontinued or LTFU before the end of 1 year of study participation will be replaced (see protocol to review study visit activities that will occur). At the Randomization Visit, enrolled subjects will be randomized into one of two treatment groups in a 1:1 manner. Group 1: Placebo vehicle; (2) placebo capsules following AM meal, (2) placebo capsules following PM meal Group 2: 800mg TCT; (2) 200mg TCT capsules following AM meal, (2) 200mg TCT capsules following PM meal.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Vehicle | Placebo comparator | Other: PlaceboSubjects will take 2 placebo capsules following AM meal, 2 placebo capsules following PM capsules |
| Tocotrienol supplement | Active comparator | Drug: Tocotrienol (TCT)Subjects will take (2) 200 mg TCT capsules following AM meal, (2) 200 mg TCT following PM meal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 17 with <25% change in MELD over the past 60 days prior to enrollment (*Total number of patients with MELD of 8-9 or MELD of 16-17 cannot exceed 40% of cohort)
- Able to speak and understand English
Key exclusion criteria (18 listed)
- Rapid deterioration of liver function, as defined by an increase in MELD score ≥25% over the past 60 days prior to enrollment
- Hepatocellular carcinoma
- Positive HIV/AIDS, or other chronic immunodeficiency
- Concurrent hepatitis B or C infection
- Current drug and/or alcohol abuse (per treating physician)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tocotrienol (TCT)TCT is a natural vitamin E supplement with a long history of safe dietary consumption in humans. The objective of the current trial is to validate the outcome observed in an earlier trial that oral TCT attenuates the rise in MELD score over time in patients with end stage liver disease/cirrhosis. | Drug | Tocotrienol supplement |
| PlaceboAlso: vehicleControl study capsule that includes no study product (Vitamin E - Tocotrienol) | Other | Placebo Vehicle |
Primary outcome
Effect of Oral tocotrienols (TCT) on Model for End-Stage Liver Disease (MELD) score.
Time frame: 3 years
Lab tests to calculate MELD score will be taken at baseline study visit and the last study visit ( Study visit 17 - 3 years) to see if Oral TCT will significantly attenuate the rise in MELD score over time in patients with End Stage Liver Disease / Cirrhosis
11 secondary outcomes
Composite clinical endpoint
Time frame: 3 yrs
Change in Child-Pugh Score
Time frame: 3 years
Change in ALT Alanine transaminase
Time frame: 3 years
Events of hepatic decompensation
Time frame: 3 yrs
New onset ascites requiring treatment with or without paracentesis
Time frame: 3 yrs
GI bleed attributed to variceal bleeding
Time frame: 3 yrs
Hepatic encephalopathy requiring treatment
Time frame: 3 yrs
Need for Liver transplant
Time frame: 3 yrs
Death
Time frame: 3 yrs
Liver fibrosis
Time frame: 3 yrs
Adverse events
Time frame: 3 yrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Background: PubMed 22298568Patel V, Rink C, Gordillo GM, Khanna S, Gnyawali U, Roy S, Shneker B, Ganesh K, Phillips G, More JL, Sarkar A, Kirkpatrick R, Elkhammas EA, Klatte E, Miller M, Firstenberg MS, Chiocca EA, Nesaretnam K, Sen CK. Oral tocotrienols are transported to human tissues and delay the progression of the model for end-stage liver disease score in patients. J Nutr. 2012 Mar;142(3):513-9. doi: 10.3945/jn.111.151902. Epub 2012 Feb 1.
- Background: PubMed 11826411Chitturi S, Abeygunasekera S, Farrell GC, Holmes-Walker J, Hui JM, Fung C, Karim R, Lin R, Samarasinghe D, Liddle C, Weltman M, George J. NASH and insulin resistance: Insulin hypersecretion and specific association with the insulin resistance syndrome. Hepatology. 2002 Feb;35(2):373-9. doi: 10.1053/jhep.2002.30692.
- Background: PubMed 24185985Ray K. NAFLD-the next global epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):621. doi: 10.1038/nrgastro.2013.197. No abstract available.
- Background: PubMed 24587650Schwenger KJ, Allard JP. Clinical approaches to non-alcoholic fatty liver disease. World J Gastroenterol. 2014 Feb 21;20(7):1712-23. doi: 10.3748/wjg.v20.i7.1712.
- Background: PubMed 16116629Schwimmer JB, Behling C, Newbury R, Deutsch R, Nievergelt C, Schork NJ, Lavine JE. Histopathology of pediatric nonalcoholic fatty liver disease. Hepatology. 2005 Sep;42(3):641-9. doi: 10.1002/hep.20842.
- Background: PubMed 24921212Review Team; LaBrecque DR, Abbas Z, Anania F, Ferenci P, Khan AG, Goh KL, Hamid SS, Isakov V, Lizarzabal M, Penaranda MM, Ramos JF, Sarin S, Stimac D, Thomson AB, Umar M, Krabshuis J, LeMair A; World Gastroenterology Organisation. World Gastroenterology Organisation global guidelines: Nonalcoholic fatty liver disease and nonalcoholic steatohepatitis. J Clin Gastroenterol. 2014 Jul;48(6):467-73. doi: 10.1097/MCG.0000000000000116. No abstract available.
- Background: PubMed 16257640Khanna S, Patel V, Rink C, Roy S, Sen CK. Delivery of orally supplemented alpha-tocotrienol to vital organs of rats and tocopherol-transport protein deficient mice. Free Radic Biol Med. 2005 Nov 15;39(10):1310-9. doi: 10.1016/j.freeradbiomed.2005.06.013.
- Background: PubMed 23632968Khanna S, Rink C, Ghoorkhanian R, Gnyawali S, Heigel M, Wijesinghe DS, Chalfant CE, Chan YC, Banerjee J, Huang Y, Roy S, Sen CK. Loss of miR-29b following acute ischemic stroke contributes to neural cell death and infarct size. J Cereb Blood Flow Metab. 2013 Aug;33(8):1197-206. doi: 10.1038/jcbfm.2013.68. Epub 2013 May 1.
- Background: PubMed 16166580Khanna S, Roy S, Slivka A, Craft TK, Chaki S, Rink C, Notestine MA, DeVries AC, Parinandi NL, Sen CK. Neuroprotective properties of the natural vitamin E alpha-tocotrienol. Stroke. 2005 Oct;36(10):2258-64. doi: 10.1161/01.STR.0000181082.70763.22. Epub 2005 Sep 15.
- Background: PubMed 21719775Park HA, Kubicki N, Gnyawali S, Chan YC, Roy S, Khanna S, Sen CK. Natural vitamin E alpha-tocotrienol protects against ischemic stroke by induction of multidrug resistance-associated protein 1. Stroke. 2011 Aug;42(8):2308-14. doi: 10.1161/STROKEAHA.110.608547. Epub 2011 Jun 30.
- Background: PubMed 16984003Patel V, Khanna S, Roy S, Ezziddin O, Sen CK. Natural vitamin E alpha-tocotrienol: retention in vital organs in response to long-term oral supplementation and withdrawal. Free Radic Res. 2006 Jul;40(7):763-71. doi: 10.1080/10715760600672491.
- Background: PubMed 21673716Rink C, Christoforidis G, Khanna S, Peterson L, Patel Y, Khanna S, Abduljalil A, Irfanoglu O, Machiraju R, Bergdall VK, Sen CK. Tocotrienol vitamin E protects against preclinical canine ischemic stroke by inducing arteriogenesis. J Cereb Blood Flow Metab. 2011 Nov;31(11):2218-30. doi: 10.1038/jcbfm.2011.85. Epub 2011 Jun 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chandan K Sen, Ph.D study chair
University of Pittsburgh
Raj Vuppalanchi, M.D. principal investigator
Indiana Unviersity School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocotrienol (TCT) in people with End Stage Liver Disease and NASH - Nonalcoholic Steatohepatitis, run by Chandan Sen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Oral tocotrienols (TCT) on Model for End-Stage Liver Disease (MELD) score. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02581085, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.