Loading clinical trials...

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

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 Liver Fibrosis

NCT04048876•Celgene

View on ClinicalTrials.gov

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 Non-alcoholic Steatohepatitis (NASH) participants with Stage 2, Stage 3 liver 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (142)

Saint Joseph's Hosptial and Medical Center - Barrow Neurological Institute

Phoenix, Arizona, United States

Mayo Clinic Phoenix

Phoenix, Arizona, United States

UC San Diego School of Medicine

La Jolla, California, United States

Cedars-Sinai Comprehensive Transplant Center

Los Angeles, California, United States

California Liver Research Institute

Pasadena, California, United States

Inland Empire Liver Foundation

Rialto, California, United States

University of California Davis Medical Center

Sacramento, California, United States

Southern California GI & Liver Centers

San Clemente, California, United States

University of Colorado, School of Medicine - Hepatology Clinic - Anschutz

Aurora, Colorado, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Key Dates

Start Date

August 14, 2019

Primary Completion Date

September 28, 2021

Completion Date

September 28, 2021

Last Updated

June 7, 2023

Enrollment

ACTUAL participants

Conditions

Non-alcoholic Fatty Liver DiseaseLiver Cirrhosis

Interventions

CC-90001

DRUG

Placebo

DRUG

Identification of Liver Fibrosis Biomarkers

NCT06819917

Non-alcoholic Fatty LiverNon-Alcoholic Fatty Liver Disease+1 more

View study

RECRUITING

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

NCT06169592

Liver CirrhosisLiver Transplant; Complications

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study to Evaluate the Efficacy and Safety of CC-90001 in Participants With Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis

Exclusion Criteria

Identification of Liver Fibrosis Biomarkers

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH

Non-Invasive Diagnostic Tests for MASLD in Pediatric Population

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis