A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-90001 IN SUBJECTS WITH NON-ALCOHOLIC STEATOHEPATITIS (NASH) AND STAGE 3 OR STAGE 4 LIVER FIBROSIS

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

The study aims to evaluate The effect of oral (PO) CC-90001, administered once daily (QD), compared with placebo, will be evaluated in subjects with NASH and Stage 3 fibrosis and explored in subjects with NASH and Stage 4 fibrosis.

This study is designed to assess response to treatment on measures of fibrosis and other efficacy parameters.

It will also assess dose response and overall safety.

 

Description

All study related examinations, labs and study medication will be provided at no cost. Compensation for time and travel available.

Details
Condition LIVER DISEASE, Liver Disorders
Clinical Study IdentifierTX228692
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: LIVER DISEASE or Liver Disorders?
Key Inclusion Criteria: Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 3 or Stage 4 fibrosis based of the non-alcoholic steatohepatitis (NASH) Clinical Research Network (CRN) Histologic Scoring System and a nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) of 4 or higher

Exclusion Criteria

Key Exclusion Criteria: History or evidence of decompensated liver disease, Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH)
Subject has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening
History or positive screen for human immunodeficiency virus (HIV) infection or congenital or human immunodeficiency virus (HIV)-unrelated acquired immunodeficiencies (eg, common variable immunodeficiency [CVID])
History of hepatitis B and/or hepatitis C
History of malignancy (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ with no recurrence in 5 years)
Pregnancy or lactation
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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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