ACTIVE_NOT_RECRUITING

Study to Evaluate the Efficacy and Safety of K-877-ER and CSG452 in Participants With NASH With Liver Fibrosis

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Conditions

NASH

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A study to investigate the use of combination therapy with two investigational products for the treatment of adult patients with Nonalcoholic steatohepatitis (NASH).

Official Title

Study to Evaluate the Efficacy and Safety of Combination Therapy of K-877-ER and CSG452 in Participants With Noncirrhotic Nonalcoholic Steatohepatitis (NASH) With Liver Fibrosis

Quick Facts

Study Start:2022-11-14
Study Completion:2026-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05327127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to understand and comply with study procedures and give written informed consent
  2. * Age ≥18 years
  3. * 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
  4. * 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
  5. * Meet all inclusion criteria outlined in clinical study protocol
  1. * Participation in another clinical trial involving an investigational agent within 30 days prior to signing the Informed Consent Form (ICF) for this study
  2. * Ongoing or recent consumption of Greater than moderate amounts of alcohol as defined in clinical study protocol
  3. * Evidence of other forms of chronic liver disease as defined in clinical study protocol
  4. * Does not meet any other exclusion criteria outlined in clinical study protocol

Contacts and Locations

Principal Investigator

Shona Pendse, MD, MMSc
STUDY_CHAIR
Kowa Research Institute, Inc.

Study Locations (Sites)

Adobe Clinical Research, LLC
Tucson, Arizona, 85712
United States
Arizona Liver Health
Tucson, Arizona, 85712
United States
Arcare Center for Clinical Research
Little Rock, Arkansas, 72205
United States
Clinical Trials Research
Lincoln, California, 95648
United States
United Clinical Research Institute
Los Alamitos, California, 90720
United States
Velocity Clinical Research
Los Angeles, California, 90057
United States
Alliance Clinical Research
Poway, California, 92064
United States
Nature Coast Clinical Research, LLC
Inverness, Florida, 34452
United States
ENCORE Borland Groover Clinical Research
Jacksonville, Florida, 32256
United States
Miami Clinical Research
Miami, Florida, 33155
United States
Ocala GI Research
Ocala, Florida, 34471
United States
Sensible Healthcare Clinical Research, LLC
Ocoee, Florida, 34761
United States
Centricity Research
Columbus, Georgia, 31904
United States
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
United States
Iowa Digestive Disease Center
Clive, Iowa, 50325
United States
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
United States
Mid-Atlantic GI Research, LLC
Greenbelt, Maryland, 20770
United States
Boston Medical Center Boston University Chobanian & Avedisian School of Medicine
Boston, Massachusetts, 02118
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
GI Alliance Research
Flowood, Mississippi, 39232
United States
GI Associates Research, LLC
Columbia, Missouri, 65201
United States
Jefferson City Medical Group
Jefferson City, Missouri, 65109
United States
Lucas Research, Inc.
Morehead City, North Carolina, 28557
United States
DSI Research Northridge, LLC
Dayton, Ohio, 45414
United States
Penn State Health/Penn State College of Medicine
Hershey, Pennsylvania, 17033
United States
GI Alliance Research
Cedar Park, Texas, 78613
United States
GI Alliance Research
Dallas, Texas, 75246
United States
GI Alliance Research
Garland, Texas, 75044
United States
GLRI McAllen Research
Pharr, Texas, 78577
United States
Northeast Clinical Rsearch of San Antonio
San Antonio, Texas, 78233
United States
Endeavor Clinical Trials
San Antonio, Texas, 78240
United States
Impact Research Institute
Waco, Texas, 76710
United States
Digestive Health Research of Central Texas, LLC
Waco, Texas, 76712
United States
North Richmond Health Research
Richmond, Virginia, 23229
United States
GI Select Health Research
Richmond, Virginia, 23236
United States
Centricity
Suffolk, Virginia, 23435
United States
Liver Institute Northwest
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Kowa Research Institute, Inc.

  • Shona Pendse, MD, MMSc, STUDY_CHAIR, Kowa Research Institute, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-14
Study Completion Date2026-03

Study Record Updates

Study Start Date2022-11-14
Study Completion Date2026-03

Terms related to this study

Additional Relevant MeSH Terms

  • NASH