Status:
TERMINATED
Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis
Lead Sponsor:
Celgene
Conditions:
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, multinational, dose-finding study evaluating the efficacy of three treatment doses of CC-90001 compared with placebo, in N...
Eligibility Criteria
Inclusion
- 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
- \- Key Exclusion Criteria
- History or evidence of decompensated liver disease,
- Hepatitis and fibrosis more likely related to etiologies other than non-alcoholic steatohepatitis (NASH).
- Participant 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 within the last 5 years (exceptions: excised and cured basal/squamous cell skin carcinomas and cervical carcinoma in situ).
- Pregnancy or lactation.
Key Trial Info
Start Date :
August 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 28 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04048876
Start Date
August 14 2019
End Date
September 28 2021
Last Update
June 7 2023
Active Locations (142)
Enter a location and click search to find clinical trials sorted by distance.
1
Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
2
Mayo Clinic Phoenix
Phoenix, Arizona, United States, 85054
3
UC San Diego School of Medicine
La Jolla, California, United States, 92093-0960
4
Cedars-Sinai Comprehensive Transplant Center
Los Angeles, California, United States, 90048