A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)

April 19, 2024 updated by: Target PharmaSolutions, Inc.
TARGET-NASH is a longitudinal observational cohort study of patients being managed for NASH and related conditions across the entire spectrum NAFLD in usual clinical practice. TARGET-NASH is a research registry of patients with NAFL or NASH within academic and community real-world practices maintained in order to assess the safety and effectiveness of current and future therapies.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Aachen, Germany
        • Recruiting
        • Universitätsklinikum Aachen
        • Contact:
      • Berlin, Germany
    • Hesse
      • Frankfurt, Hesse, Germany, 60590
        • Recruiting
        • Universitätsklinikum Frankfurt
        • Contact:
  • Spain
    • Cantabria
      • Santander, Cantabria, Spain
        • Recruiting
        • Hospital Marques de Valdecilla
        • Contact:
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Terminated
        • Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
      • Pasadena, California, United States, 91105
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California, Davis
        • Contact:
      • San Jose, California, United States, 95128
        • Recruiting
        • Silicon Valley Research Institute
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Connecticut
      • Hartford, Connecticut, United States, 06106
      • Hartford, Connecticut, United States, 06105
        • Terminated
        • Connecticut Gastroenterology
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Terminated
        • Medstar Georgetown Transplant Institute
    • Florida
      • Clearwater, Florida, United States, 33762
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Kenneth Cusi, MD
        • Contact:
      • Gainesville, Florida, United States, 32610-0272
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • UF Health Gastroenterology
        • Contact:
      • Miami, Florida, United States, 33009
      • Miami, Florida, United States, 33136
        • Recruiting
        • Schiff Center for Liver Disease/University of Miami
        • Contact:
      • Orlando, Florida, United States, 32804
      • Palm Harbor, Florida, United States, 34041
        • Recruiting
        • Advanced Gastroenterology Associates, LLC
        • Contact:
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Medical Group
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30322
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Terminated
        • Northwestern Medicine, Digestive Health Center
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • NorthShore University HealthSystem
        • Contact:
        • Principal Investigator:
          • Liana Billings, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University - Division of Gastroenterology and Hepatology
        • Contact:
          • Emily Smith
          • Phone Number: 317-274-1692
          • Email: es37@iu.edu
      • Indianapolis, Indiana, United States, 46237
        • Terminated
        • Indianapolis Gastroenterology Research Foundation
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Houma, Louisiana, United States, 70360
        • Withdrawn
        • Houma Digestive Health Specialists
      • New Orleans, Louisiana, United States, 70112
        • Terminated
        • Tulane University School of Medicine
      • Shreveport, Louisiana, United States, 71105
        • Terminated
        • Louisiana Research Center, LLC
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • Missouri
      • Saint Louis, Missouri, United States, 63104
        • Recruiting
        • Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Terminated
        • Rutgers - Robert Wood Johnson Medical School
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • The Children's Hospital at Montefiore, Division of Pediatric GI
        • Contact:
      • Manhasset, New York, United States, 11030
        • Terminated
        • NorthWell Health - North Shore University Hospital
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medical College
        • Contact:
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Terminated
        • Asheville Gastroenterology Associates, PA
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
      • Charlotte, North Carolina, United States, 28204
        • Terminated
        • Center for Liver Disease and Transplant at CMC
      • Durham, North Carolina, United States, 27710
        • Terminated
        • Duke University Medical Center
      • Morehead City, North Carolina, United States, 28557
        • Terminated
        • Carteret Medical Group
      • Winston-Salem, North Carolina, United States, 27103
        • Terminated
        • Digestive Health Specialists, PA
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cincinnati, Ohio, United States, 45229-3039
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Children's
        • Contact:
      • Columbus, Ohio, United States, 43203
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • The Children's Hospital at Oklahoma University Medical Center
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19134
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
      • Greenville, South Carolina, United States, 29615
        • Withdrawn
        • Gastroenterology Associates
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Children's Health - Children's Medical Center Dallas
        • Contact:
        • Principal Investigator:
          • Sarah Barlow, MD
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77030
        • Terminated
        • Research Specialists of Texas
      • Live Oak, Texas, United States, 78233
        • Terminated
        • Pinnacle Clinical Research
    • Vermont
      • Burlington, Vermont, United States, 05401
        • Recruiting
        • University of Vermont Medical Center
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Recruiting
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
      • Richmond, Virginia, United States, 23226
        • Recruiting
        • Bon Secours Liver Institute of Virginia
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98104
        • Terminated
        • University of Washington
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin Hospital & Clinics
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adults and children with NAFL or NASH who are being seen specifically to address this disease process

Description

Inclusion Criteria:

1. Adults and children (age 2 or older) being managed or treated for nonalcoholic fatty liver disease. Diagnosis is based on the clinical judgement of the care provider.

Exclusion Criteria:

1. Inability to provide informed assent/consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establish an understanding of the current natural history of NASH at academic and community medical centers
Time Frame: 10 years
A detailed analysis of demographics, concurrent medications, metabolic and cardiovascular co-morbidities, staging of liver disease, and outcomes for patients with NASH managed in diverse clinical settings will serve as an important comparator for subsequent interventions that alter the treatment paradigm for this disease.
10 years
Evaluate NASH treatment regimens being used in clinical practice
Time Frame: 10 years
Currently, there are no FDA approved therapies for NASH, however clinicians may use a variety of interventions including diet and exercise programs, vitamin E, bariatric surgery or other unapproved uses of some cholesterol, lipid lowering, anti-diabetic and anti-inflammatory medications as well as alternative medications. TARGET-NASH will monitor the safety and effectiveness of the various treatment choices in enrolled patients.
10 years
Examine populations underrepresented in phase II-III clinical trials
Time Frame: 10 years
Patients with cirrhosis, age > 70, patients who consume moderate amounts of alcohol and patients with multiple comorbidities such as severe depression, chronic fatigue, fibromyalgia, type 2 diabetes, inflammatory bowel disease, or cardiovascular disease.
10 years
Evaluate optimal duration and combination of NASH therapies to achieve clinical response and clinical remission
Time Frame: 10 years
In addition to diet and exercise, type, dose and duration of therapy of each NASH treatment (both current unapproved therapies and future FDA approved drugs) will be closely followed, with a goal to monitor treatment paradigms and various combination regimens for clinical response and clinical remission.
10 years
Examine liver histology
Time Frame: 10 years
10 years
Estimate adverse event frequency and severity and describe management practices
Time Frame: 10 years
NASH can often be an asymptomatic disease in the setting of other disease-related comorbidities such as diabetes and cardiovascular disease. Once NASH progresses to cirrhosis, these patients can suffer the attendant complications of decompensated liver disease including debilitating fatigue, muscle wasting, ascites, bleeding, encephalopathy, hepatocellular carcinoma, and death. NASH therapies may increase the frequency and severity of certain adverse events, such as edema (pioglitazone), some cancers (vitamin E), and new agents or combinations of agents may have their own unique adverse event profiles and varying needs for management plans (e.g., pruritus and dyslipidemia).
10 years
Evaluate the impact of NASH therapies on medical co-morbidities
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Target PharmaSolutions, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start

July 1, 2016

Primary Completion (Estimated)

July 1, 2036

Study Completion (Estimated)

July 1, 2036

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimated)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TARGET-NASH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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