Active — Not RecruitingPhase 2

Tocotrienol Against the Progression of End Stage Liver Disease

United States70 participantsStarted 2019-11-01

Plain-language 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. 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.

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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
✕. 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

What they're measuring

Effect of Oral tocotrienols (TCT) on Model for End-Stage Liver Disease (MELD) score.

Timeframe: 3 years

Trial details

NCT IDNCT02581085

SponsorChandan Sen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-16

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