Last updated 5 months ago
Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis
200 patients around the world
Available in Brazil, Argentina
Kowa Research Institute, Inc.
15Research sites
200Patients around the world
This study is for people with
Fatty liver/nash
Hepatic steatosis
Nonalcoholic steatohepatitis
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Able to understand and comply with study procedures and give written informed consent.Age ≥18 years.NAS ≥4 with a score of at least 1 in each component of the NAS (steatosis, lobular inflammation, and ballooning) at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization.Fibrosis stage of 1 or greater and below 4 on NASH CRN (Clinical Research Network) fibrosis staging system at Visit 2 liver biopsy, or a historical liver biopsy performed within 24 weeks of randomization.Meet all inclusion criteria outlined in clinical study protocol.
- Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study.Ongoing or recent consumption of greater than moderate amounts of alcohol as defined in clinical study protocol.Evidence of other forms of chronic liver disease as defined in clinical study protocol.Does not meet any other exclusion criteria outlined in clinical study protocol.
Sites
CIPREC Centro de Investigación y Prevención Cardiovascular - CABA
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Centro de Investigaciones Metabólicas (CINME) S.A. - CABA, Buenos Aires
Recruiting
Hospital Provincial del Centenario - Rosario, Santa Fe
Recruiting
Hospital Británico de Buenos Aires - CABA
Recruiting
Centro Médico Saavedra
Recruiting
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Hospital Italiano de La Plata
Recruiting
Centro de Investigaciones Médicas Mar del Plata SRL
Recruiting
Hospital Universitario Austral - Pilar
Recruiting
SponsorKowa Research Institute, Inc.
Conditions
Hepatic steatosisNonalcoholic steatohepatitis
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05327127
