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NCT02217475 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis

A Phase 2 study of Nonalcoholic Steatohepatitis, sponsored by Tobira Therapeutics.

Completed
Registry status
Phase 2
Development phase
289
Enrollment target
20
Study locations

NCT02217475: Completed Phase 2 study of Nonalcoholic Steatohepatitis, sponsored by Tobira Therapeutics.

NCT02217475 is a Phase 2 study of Nonalcoholic Steatohepatitis that has completed, run by Tobira Therapeutics. The registered enrollment target is 289 participants, below the 693-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02217475, a Phase 2 study of Nonalcoholic Steatohepatitis, has completed, sponsored by Tobira Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
289 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.

Primary Outcome

Hepatic histological improvement in Nonalcoholic Fatty Liver Disease Activity Score (NAS) at Year 1 was defined as a decrease (improvement) in NAS by ≥ 2 with at least a 1-point reduction in either lobular inflammation or hepatocellular ballooning and with no concurrent worsening of fibrosis stage. The NAS was derived as the unweighted sum of steatosis (0 to 3), lobular inflammation (0 to 3), and hepatocellular ballooning (0 to 2) scores. The NAS ranges from 0-8 with the higher score indicating

Interventions

  • DRUG Placebo
  • DRUG Cenicriviroc

Study Locations (20)

California

  • - Rialto
  • - San Diego
  • - San Diego
  • - San Francisco

Maryland

  • - Baltimore
  • - Baltimore
  • - Chevy Chase
  • - Lutherville

Arizona

  • - Phoenix
  • - Tucson

Florida

  • - Miami
  • - Tampa

Massachusetts

  • - Boston
  • - Worcester

Alabama

  • - Dothan

Colorado

  • - Littleton

Illinois

  • - Chicago

Trial Details

FieldValue
Enrollment Target 289 participants
Start Date 2014-09-18
Est. Completion 2017-06-22
Phase Phase 2
Tobira Therapeutics

11 total trials

What the finished NCT02217475 record still lists

NCT02217475 is an interventional study that assigns participants to a tested intervention. The registered 289 participants enrollment target is mid-sized for trials with a published cap, below the 693-participant average among 30 other Nonalcoholic Steatohepatitis trials with a reported enrollment target (58% lower).

The record links to 1 condition, with Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02217475 names 20 study sites across 11 states, led by California, Maryland, Arizona.

Frequently Asked Questions

What is clinical trial NCT02217475 about?

NCT02217475 is a clinical study titled "Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis". The purpose of this study is to determine whether cenicriviroc is effective and safe in the treatment of nonalcoholic steatohepatitis (NASH) in adult participants with liver fibrosis.

What is the current status of trial NCT02217475?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 289 participants. The study started on 2014-09-18. Estimated completion is 2017-06-22.

What conditions does trial NCT02217475 study?

This clinical trial studies the following conditions: Nonalcoholic Steatohepatitis.

What interventions are being tested in trial NCT02217475?

The interventions under investigation include: Placebo (DRUG), Cenicriviroc (DRUG).

Who is sponsoring clinical trial NCT02217475?

This trial is sponsored by Tobira Therapeutics, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02217475 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Nonalcoholic Steatohepatitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02217475's enrollment target sits among peer trials

289 7th of 30 higher than 24 of 30 other Nonalcoholic Steatohepatitis trials

participants (enrollment target), bucketed by value

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

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

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Source: ClinicalTrials.gov NCT02217475, the US trial registry maintained by the National Library of Medicine. NCT02217475 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.