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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: Active Phase 2 study of NASH - Nonalcoholic Steatohepatitis and End Stage Liver DIsease, sponsored by Chandan Sen.
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 259-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Tocotrienol (TCT)
Study Locations (1)
Indiana
- IU Health Unviersity Hospital - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2019-11-01 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What the registry record for NCT02581085 still lists
NCT02581085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 259-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (73% lower).
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 a single indexed study location in 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 - Non-Alcoholic 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.
Learn More About Clinical Trials
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Where NCT02581085's enrollment target sits among peer trials
70 16th of 28 higher than 11 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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