Active, Not Recruiting
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis - CC-90001-NASH-001
Updated:
31 August, 2021
|
ClinicalTrials.gov
Phase
Gender(s)
Age Range
Active, Not Recruiting
Inclusion Criteria: - Key Inclusion Criteria Diagnosis of non-alcoholic steatohepatitis (NASH) with presence of Stage 2, Stage 3 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 1. History or evidence of decompensated liver disease, 2. Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH). 3. Participant has urine ethyl glucuronide (EtG) > 500 ng/mL at Screening. 4. 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]). 5. History of hepatitis B and/or hepatitis C. 6. History of malignancy within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ). 7. Pregnancy or lactation.
We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information
MLTNO2000046