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

NCT ID: NCT02815891

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

15000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2036-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Target PharmaSolutions, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic

Phoenix, Arizona, United States

Site Status TERMINATED

Stanford University

Palo Alto, California, United States

Site Status TERMINATED

California Liver Research Institute

Pasadena, California, United States

Site Status TERMINATED

University of California, Davis

Sacramento, California, United States

Site Status TERMINATED

Silicon Valley Research Institute

San Jose, California, United States

Site Status TERMINATED

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status TERMINATED

Connecticut Gastroenterology

Hartford, Connecticut, United States

Site Status TERMINATED

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Site Status TERMINATED

Medstar Georgetown Transplant Institute

Washington D.C., District of Columbia, United States

Site Status TERMINATED

Gastro Florida

Clearwater, Florida, United States

Site Status TERMINATED

University of Florida Hepatology Research at CTRB

Gainesville, Florida, United States

Site Status TERMINATED

University of Florida

Gainesville, Florida, United States

Site Status TERMINATED

UF Health Gastroenterology

Jacksonville, Florida, United States

Site Status TERMINATED

University of Miami

Miami, Florida, United States

Site Status TERMINATED

Schiff Center for Liver Disease/University of Miami

Miami, Florida, United States

Site Status TERMINATED

AdventHealth Diabetes Institute

Orlando, Florida, United States

Site Status TERMINATED

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, United States

Site Status TERMINATED

Tampa General Medical Group

Tampa, Florida, United States

Site Status TERMINATED

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, United States

Site Status TERMINATED

Emory University - Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status ACTIVE_NOT_RECRUITING

Northwestern Medicine, Digestive Health Center

Chicago, Illinois, United States

Site Status TERMINATED

Rush University Medical Center

Chicago, Illinois, United States

Site Status COMPLETED

NorthShore University HealthSystem

Skokie, Illinois, United States

Site Status TERMINATED

Indiana University - Division of Gastroenterology and Hepatology

Indianapolis, Indiana, United States

Site Status TERMINATED

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, United States

Site Status TERMINATED

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status TERMINATED

University of Louisville

Louisville, Kentucky, United States

Site Status TERMINATED

Houma Digestive Health Specialists

Houma, Louisiana, United States

Site Status WITHDRAWN

Tulane University School of Medicine

New Orleans, Louisiana, United States

Site Status TERMINATED

Louisiana Research Center, LLC

Shreveport, Louisiana, United States

Site Status TERMINATED

Mercy Medical Center

Baltimore, Maryland, United States

Site Status TERMINATED

University of Michigan

Ann Arbor, Michigan, United States

Site Status ACTIVE_NOT_RECRUITING

Mayo Clinic

Rochester, Minnesota, United States

Site Status TERMINATED

Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit

St Louis, Missouri, United States

Site Status TERMINATED

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status TERMINATED

Rutgers - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status TERMINATED

NorthWell Health - North Shore University Hospital

Manhasset, New York, United States

Site Status TERMINATED

Weill Cornell Medical College

New York, New York, United States

Site Status TERMINATED

Columbia University Medical Center

New York, New York, United States

Site Status TERMINATED

The Children's Hospital at Montefiore, Division of Pediatric GI

The Bronx, New York, United States

Site Status TERMINATED

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, United States

Site Status TERMINATED

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status TERMINATED

Center for Liver Disease and Transplant at CMC

Charlotte, North Carolina, United States

Site Status TERMINATED

Duke University Medical Center

Durham, North Carolina, United States

Site Status TERMINATED

Carteret Medical Group

Morehead City, North Carolina, United States

Site Status TERMINATED

Digestive Health Specialists, PA

Winston-Salem, North Carolina, United States

Site Status TERMINATED

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status TERMINATED

University of Cincinnati

Cincinnati, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

Cleveland Clinic Children's

Cleveland, Ohio, United States

Site Status TERMINATED

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status TERMINATED

The Children's Hospital at Oklahoma University Medical Center

Oklahoma City, Oklahoma, United States

Site Status TERMINATED

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status TERMINATED

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, United States

Site Status TERMINATED

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Site Status TERMINATED

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status TERMINATED

Gastroenterology Associates

Greenville, South Carolina, United States

Site Status WITHDRAWN

Children's Health - Children's Medical Center Dallas

Dallas, Texas, United States

Site Status TERMINATED

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, United States

Site Status TERMINATED

Research Specialists of Texas

Houston, Texas, United States

Site Status TERMINATED

Pinnacle Clinical Research

Live Oak, Texas, United States

Site Status TERMINATED

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status TERMINATED

University of Virginia

Charlottesville, Virginia, United States

Site Status TERMINATED

Bon Secours Liver Institute of Virginia

Richmond, Virginia, United States

Site Status ACTIVE_NOT_RECRUITING

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status RECRUITING

University of Washington

Seattle, Washington, United States

Site Status TERMINATED

West Virginia University

Morgantown, West Virginia, United States

Site Status TERMINATED

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, United States

Site Status TERMINATED

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, Germany

Site Status RECRUITING

Universitätsklinikum Aachen

Aachen, , Germany

Site Status RECRUITING

Charite Berlin

Berlin, , Germany

Site Status RECRUITING

Hospital Marques de Valdecilla

Santander, Cantabria, Spain

Site Status RECRUITING

Hospital Clínic i Provincial de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Hospital Virgen del Rocio

Seville, , Spain

Site Status RECRUITING

Hospital La Fe

Valencia, , Spain

Site Status RECRUITING

Countries

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United States Germany Spain

Central Contacts

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Ellie Michalski

Role: CONTACT

Email: [email protected]

Facility Contacts

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Alanda Perry Jones

Role: primary

Stefan Zeuzem, MD

Role: primary

Angela Breuer

Role: primary

Markus Reib

Role: primary

Lorena C Estrada

Role: primary

Isabel Graupera

Role: primary

Jose Manuel Caro Vega

Role: primary

Sara Mascort Arques

Role: backup

Almundena Cubells Garcia

Role: primary

Laura Consuelo Arnal

Role: backup

References

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Sanyal AJ, Munoz B, Cusi K, Barritt AS 4th, Muthiah M, Mospan AR, Reddy KR, Firpi-Morell R, Thuluvath PJ, Bhamidimarri KR, Fried MW; TARGET-NASH Investigators. Validation of a Clinical Risk-based Classification System in a Large Nonalcoholic Fatty Liver Disease Real-world Cohort. Clin Gastroenterol Hepatol. 2023 Oct;21(11):2889-2900.e10. doi: 10.1016/j.cgh.2023.02.024. Epub 2023 Mar 5.

Reference Type DERIVED
PMID: 36871772 (View on PubMed)

Malespin MH, Barritt AS 4th, Watkins SE, Schoen C, Tincopa MA, Corbin KD, Mospan AR, Munoz B, Trinh HN, Weiss LM, Reddy KR, Loomba R, Kemmer N, Lok AS. Weight Loss and Weight Regain in Usual Clinical Practice: Results From the TARGET-NASH Observational Cohort. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2393-2395.e4. doi: 10.1016/j.cgh.2021.01.023. Epub 2021 Jan 21.

Reference Type DERIVED
PMID: 33486083 (View on PubMed)

Weinberg EM, Trinh HN, Firpi RJ, Bhamidimarri KR, Klein S, Durlam J, Watkins S, Reddy KR, Weiss M, Zink RC, Lok AS. Lean Americans With Nonalcoholic Fatty Liver Disease Have Lower Rates of Cirrhosis and Comorbid Diseases. Clin Gastroenterol Hepatol. 2021 May;19(5):996-1008.e6. doi: 10.1016/j.cgh.2020.06.066. Epub 2020 Jul 3.

Reference Type DERIVED
PMID: 32629123 (View on PubMed)

Other Identifiers

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TARGET-NASH

Identifier Type: -

Identifier Source: org_study_id