Liver Trial on Oral Tocotrienol
| Status: | Recruiting |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/4/2019 |
| Start Date: | April 2019 |
| End Date: | February 2022 |
| Contact: | Jennifer Mohnacky, RN |
| Email: | jmohnack@iu.edu |
| Phone: | 317-278-2715 |
Tocotrienol Against the Progression of End Stage Liver Disease
The purpose of this Phase IIA trial is to validate the outcome observed in the Phase I trial
that oral TCT attenuates the rise in MELD over time in patients diagnosed with NAFLD, NASH or
chronically infected hepatitis C. Subjects will participate for 3 years. They will be asked
to come to 8 total study visits and will receive 6 follow-up phone calls within the 3 years
of participation. Subjects will be asked to take 2 study capsules of vitamin E Tocotrienol
(200mg) twice a day or 2 placebo capsules twice a day. The study is randomized and study
staff will be blinded to randomization.
that oral TCT attenuates the rise in MELD over time in patients diagnosed with NAFLD, NASH or
chronically infected hepatitis C. Subjects will participate for 3 years. They will be asked
to come to 8 total study visits and will receive 6 follow-up phone calls within the 3 years
of participation. Subjects will be asked to take 2 study capsules of vitamin E Tocotrienol
(200mg) twice a day or 2 placebo capsules twice a day. The study is randomized and study
staff will be blinded to randomization.
As a safe and natural vitamin, tocotrienol (TCT) stands uniquely poised to treat ~500 million
worldwide who suffer from viral hepatitis. Furthermore, for those awaiting liver
transplantation, TCT may buy more time until a liver becomes available. The primary purpose
of this Phase IIA trial is to validate the outcome observed in the limited sample size Phase
I trial (n=6) that oral TCT attenuates the rise in MELD over time in patients with NAFLD,
NASH, or Hepatitis C. Outcomes will direct the design of a multi-center Phase IIB 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 month, 2 months, 3 months, 6 months, 1 year, 18 months, 2 years, and 3 years. Subjects will
receive follow-up phone calls at 9 months, 15 months, 21 months, 27 months, 30 months, and 33
months. 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
worldwide who suffer from viral hepatitis. Furthermore, for those awaiting liver
transplantation, TCT may buy more time until a liver becomes available. The primary purpose
of this Phase IIA trial is to validate the outcome observed in the limited sample size Phase
I trial (n=6) that oral TCT attenuates the rise in MELD over time in patients with NAFLD,
NASH, or Hepatitis C. Outcomes will direct the design of a multi-center Phase IIB 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 month, 2 months, 3 months, 6 months, 1 year, 18 months, 2 years, and 3 years. Subjects will
receive follow-up phone calls at 9 months, 15 months, 21 months, 27 months, 30 months, and 33
months. 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
Inclusion Criteria:
- Age 18 years of above, male or female
- ESLD patients with clinically- diagnosed NAFLD, NASH, or chronically infected with
hepatitis C virus (HCV, all genotypes), with amount of virus in the blood greater than
10,000 IU/ml
- Absence of any other possible cause for liver dysfunction
- Stable MELD score of at least 8, but no greater than 15 over the past 6 months (+/- 1
month) prior to enrollment
- 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
Exclusion Criteria:
- Rapid deterioration of liver function, over the past 6 months (+/- 1 month) prior to
enrollment per study physician determination
- Hepatocellular carcinoma
- Positive HIV/ AIDS, or other chronic immunodeficiency
- Concurrent hepatitis A or B infection
- Current drug and/or alcohol abuse (per treating physician)
- Bacterial infection at time of enrollment
- Daily use of dedicated vitamin E supplementation within the 12 months prior to study
participation
- Platelets <25,000 cells/µL, neutrophils <1000 cells/µL, hemoglobin <8g/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
- Patients receiving medications known to treat Hepatitis C; patients who begin taking
these medications during the course of study participation will be dropped.
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