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

NCT02815891 | Completed

• 1 other identifier: TARGET-NASH
• Study Type: observational
• Target: 7,330
• Locations: 3 countries
• Sites: 72

Brief Summary

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.

Conditions

Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver

Outcome Measures

Primary Outcomes (7)

• Establish an understanding of the current natural history of NASH at academic and community medical centers

  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

  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

  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

  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

  10 years

• Estimate adverse event frequency and severity and describe management practices

  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

  10 years

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \. 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.

You may not qualify if:

• \. Inability to provide informed assent/consent.

Sponsors & Collaborators

• Target PharmaSolutions, Inc.: lead

Study Sites (72)

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

Phoenix, Arizona, 85006, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

California Liver Research Institute

Pasadena, California, 91105, United States

Location

University of California, Davis

Sacramento, California, 95817, United States

Location

Silicon Valley Research Institute

San Jose, California, 95128, United States

Location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Connecticut Gastroenterology

Hartford, Connecticut, 06105, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Medstar Georgetown Transplant Institute

Washington D.C., District of Columbia, 20007, United States

Location

Gastro Florida

Clearwater, Florida, 33762, United States

Location

University of Florida Hepatology Research at CTRB

Gainesville, Florida, 32610-0272, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

UF Health Gastroenterology

Jacksonville, Florida, 32207, United States

Location

University of Miami

Miami, Florida, 33009, United States

Location

Schiff Center for Liver Disease/University of Miami

Miami, Florida, 33136, United States

Location

AdventHealth Diabetes Institute

Orlando, Florida, 32804, United States

Location

Advanced Gastroenterology Associates, LLC

Palm Harbor, Florida, 34041, United States

Location

Tampa General Medical Group

Tampa, Florida, 33606, United States

Location

Atlanta Gastroenterology Associates, LLC

Atlanta, Georgia, 30308, United States

Location

Emory University - Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Northwestern Medicine, Digestive Health Center

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NorthShore University HealthSystem

Skokie, Illinois, 60077, United States

Location

Indiana University - Division of Gastroenterology and Hepatology

Indianapolis, Indiana, 46202, United States

Location

Indianapolis Gastroenterology Research Foundation

Indianapolis, Indiana, 46237, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

Louisiana Research Center, LLC

Shreveport, Louisiana, 71105, United States

Location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit

St Louis, Missouri, 63104, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68106, United States

Location

Rutgers - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08901, United States

Location

NorthWell Health - North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

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

The Bronx, New York, 10467, United States

Location

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, 28801, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Center for Liver Disease and Transplant at CMC

Charlotte, North Carolina, 28204, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Carteret Medical Group

Morehead City, North Carolina, 28557, United States

Location

Digestive Health Specialists, PA

Winston-Salem, North Carolina, 27103, United States

Location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3039, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Children's

Cleveland, Ohio, 44195, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43203, United States

Location

The Children's Hospital at Oklahoma University Medical Center

Oklahoma City, Oklahoma, 73104, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

St. Christopher's Hospital for Children

Philadelphia, Pennsylvania, 19134, United States

Location

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Children's Health - Children's Medical Center Dallas

Dallas, Texas, 75235, United States

Location

Baylor College of Medicine/Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Research Specialists of Texas

Houston, Texas, 77030, United States

Location

Pinnacle Clinical Research

Live Oak, Texas, 78233, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05401, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Bon Secours Liver Institute of Virginia

Richmond, Virginia, 23226, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington

Seattle, Washington, 98104, United States

Location

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

University of Wisconsin Hospital & Clinics

Madison, Wisconsin, 53705, United States

Location

Universitätsklinikum Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitätsklinikum Aachen

Aachen, Germany

Location

Charite Berlin

Berlin, Germany

Location

Hospital Marques de Valdecilla

Santander, Cantabria, Spain

Location

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain

Location

Hospital Virgen del Rocio

Seville, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Related Publications (3)

• 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.

  PMID: 36871772 DERIVED

• 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.

  PMID: 33486083 DERIVED

• 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.

  PMID: 32629123 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Patients enrolled in TARGET-NASH will be invited to participate in the Biorepository Specimen Bank (BSB). Blood samples for biomarker and DNA assays will be collected on a voluntary basis and participation in this project will not affect participation in the main study. These samples will be shipped to a central repository for storage to use in future studies. Samples stored at the biorepository will be identified only with the patient's unique study ID number and the date that the sample was obtained. This link between the patient's study ID number and their name will be available only at the site where the samples were obtained.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 28, 2016
• Study Start: July 1, 2016
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (65); DE (3); ES (4)