NCT02581085CompletedPhase 2
Tocotrienol Against the Progression of End Stage Liver Disease
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- First submitted
- 26 Jun 2015
- Start date
- 1 Nov 2019
- Primary completion date
- 16 Dec 2025
- Lead sponsor
- Chandan Sen
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT02581085
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 110
- From 1 Nov 2019 to the primary completion date, 16 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Rapid deterioration of liver function, as defined by an increase in MELD score ≥25% over the past 60 days prior to enrollment
- Concurrent hepatitis B or C infection
- Current drug and/or alcohol abuse (per treating physician)
- Daily use of dedicated vitamin E supplementation (greater than 100 IU per day) within the 3 months prior to study participation
- Concurrent enrollment in another interventional clinical trial
- Any weight reduction surgery in the preceding 2 years prior to screening or planned surgery during the study
Other illness
- Positive HIV/AIDS, or other chronic immunodeficiency
- Bacterial infection at time of enrollment
- History of liver transplantation
- Current or history of HCC
- 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
Lab values
- Platelets \<35,000 cells/µL, neutrophils \<1000 cells/µL, hemoglobin \<10g/dL, total bilirubin \>3mg/dL, serum creatinine \>2.0mg/dL
- ALT \>250 U/L
- AST \> 250 U/L
- Hemoglobin A1C ≥ 9.5 %
Other
- Hepatocellular carcinoma
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IU Health Unviersity Hospital Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.