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NCT02581085 · ClinicalTrials.gov registry record · Phase 2

Tocotrienol Against the Progression of End Stage Liver Disease

A Phase 2 study of NASH - Nonalcoholic Steatohepatitis and End Stage Liver DIsease, sponsored by Chandan Sen.

Active
Registry status
Phase 2
Development phase
70
Enrollment target
1
Study location

NCT02581085 is a Phase 2 study of NASH - Nonalcoholic Steatohepatitis and End Stage Liver DIsease that is active but no longer recruiting, run by Chandan Sen. The registered enrollment target is 70 participants, below the 266-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (74% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02581085, a Phase 2 study of NASH - Nonalcoholic Steatohepatitis and End Stage Liver DIsease, is active but no longer recruiting, sponsored by Chandan Sen.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
70 participants
Enrollment target
1
Study location

Study 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.

Interventions

  • OTHER Placebo
  • DRUG Tocotrienol (TCT)

Study Locations (1)

Indiana

  • IU Health Unviersity Hospital - Indianapolis

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2019-11-01
Est. Completion 2028-12-31
Phase Phase 2

Sponsor

Chandan Sen

2 total trials

What the Registry Record Tells You About NCT02581085

The ClinicalTrials.gov registry entry for NCT02581085 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 266-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (74% lower). The listed sponsor is Chandan Sen, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02581085 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.

Frequently Asked Questions

What is clinical trial NCT02581085 about?

NCT02581085 is a clinical study titled "Tocotrienol Against the Progression of End Stage Liver Disease". 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 ...

What is the current status of trial NCT02581085?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2019-11-01. Estimated completion is 2028-12-31.

What conditions does trial NCT02581085 study?

This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis, End Stage Liver DIsease, NAFLD - Nonalcoholic Fatty Liver Disease.

What interventions are being tested in trial NCT02581085?

The interventions under investigation include: Placebo (OTHER), Tocotrienol (TCT) (DRUG).

Who is sponsoring clinical trial NCT02581085?

This trial is sponsored by Chandan Sen, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02581085 being conducted?

This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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