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NCT01672866 · ClinicalTrials.gov registry record · Phase 2

Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

A Phase 2 study, sponsored by Gilead Sciences.

Terminated
Registry status
Phase 2
Development phase
222
Enrollment target

NCT01672866: Clinical Trial Phase 2 study, sponsored by Gilead Sciences.

NCT01672866 is a Phase 2 study that was terminated before completion, run by Gilead Sciences. The registered enrollment target is 222 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01672866, a Phase 2 study, was terminated before completion, sponsored by Gilead Sciences.

TERMINATED
Registry status
Phase 2
Development phase
222 participants
Enrollment target

Study Summary

The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: * Randomized Double-Blind Phase * Open-Label Phase (optional)

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL SIM

Trial Details

FieldValue
Enrollment Target 222 participants
Start Date 2012-12-05
Est. Completion 2016-12-29
Phase Phase 2
Gilead Sciences

504 total trials

Why NCT01672866 stopped before completion

NCT01672866 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% higher).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01672866 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01672866 about?

NCT01672866 is a clinical study titled "Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)". The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: * Randomized Double-Blind Phase...

What is the current status of trial NCT01672866?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 222 participants. The study started on 2012-12-05. Estimated completion is 2016-12-29.

What interventions are being tested in trial NCT01672866?

The interventions under investigation include: Placebo (BIOLOGICAL), SIM (BIOLOGICAL).

Who is sponsoring clinical trial NCT01672866?

This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01672866's enrollment target sits among peer trials

222 274th of 2000 higher than 1,726 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01672866, the US trial registry maintained by the National Library of Medicine. NCT01672866 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.