A Phase 3 Clinical Trial for Patients with Nonalcoholic Steatohepatitis (NASH)

  • STATUS
    Recruiting
  • sponsor
    Intercept
Updated on 8 November 2020

Summary

A Phase 3 Clinical Trial for Patients with Nonalcoholic Steatohepatitis (NASH)

Description

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Study Evaluating the Safety and Efficacy of Obeticholic Acid (study medication) in Subjects with Nonalcoholic Steatohepatitis (NASH).

Details
Clinical Study IdentifierTX146343
SponsorIntercept
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologic evidence of NASH upon central read of a liver biopsy obtained no more than 6 months before Day 1
Male or Female 18 years of age
Histologic evidence of fibrosis stage 2

Exclusion Criteria

Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year before Screening
Active hepatitis C virus
History of liver transplant, current placement on a liver transplant list, or MELD score >12
Histological presence of cirrhosis
Prior (at any point) or planned (during the study period) ileal resection, or prior (within 5 years before Screening) or planned (during the study period) bariatric surgery (eg, gastric bands, gastroplasty, roux-en-Y gastric bypass)
Additional eligibility criteria may apply
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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