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

Nonalcoholic Steatohepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02815891
• Other study ID #: TARGET-NASH
• Status: Recruiting
• Start date: July 2016
• Est. completion date: July 2036

Study information

• Verified date: April 2024
• Source: Target PharmaSolutions, Inc.
• Contact: Stephanie Harrison, MPH
• Phone: 919-930-2792
• Email: sharrison[@]targetrwe.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: July 2036
• Est. primary completion date: July 2036
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis

Locations

Country	Name	City	State
Germany	Universitätsklinikum Aachen	Aachen
Germany	Charite Berlin	Berlin
Germany	Universitätsklinikum Frankfurt	Frankfurt	Hesse
Spain	Hospital Clínic i Provincial de Barcelona	Barcelona
Spain	Hospital Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Virgen del Rocio	Sevilla
Spain	Hospital La Fe	Valencia
United States	University of Michigan	Ann Arbor	Michigan
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates, LLC	Atlanta	Georgia
United States	Emory University - Children's Healthcare of Atlanta	Atlanta	Georgia
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado
United States	Mercy Medical Center	Baltimore	Maryland
United States	The Children's Hospital at Montefiore, Division of Pediatric GI	Bronx	New York
United States	University of Vermont Medical Center	Burlington	Vermont
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Center for Liver Disease and Transplant at CMC	Charlotte	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Northwestern Medicine, Digestive Health Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	Gastro Florida	Clearwater	Florida
United States	Cleveland Clinic Children's	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Children's Health - Children's Medical Center Dallas	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	University of Florida Hepatology Research at CTRB	Gainesville	Florida
United States	Gastroenterology Associates	Greenville	South Carolina
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Connecticut Gastroenterology	Hartford	Connecticut
United States	Houma Digestive Health Specialists	Houma	Louisiana
United States	Baylor College of Medicine/Texas Children's Hospital	Houston	Texas
United States	Research Specialists of Texas	Houston	Texas
United States	Indiana University - Division of Gastroenterology and Hepatology	Indianapolis	Indiana
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	UF Health Gastroenterology	Jacksonville	Florida
United States	Pinnacle Clinical Research	Live Oak	Texas
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin Hospital & Clinics	Madison	Wisconsin
United States	NorthWell Health - North Shore University Hospital	Manhasset	New York
United States	Schiff Center for Liver Disease/University of Miami	Miami	Florida
United States	University of Miami	Miami	Florida
United States	Carteret Medical Group	Morehead City	North Carolina
United States	West Virginia University	Morgantown	West Virginia
United States	Rutgers - Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	The Children's Hospital at Oklahoma University Medical Center	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	AdventHealth Diabetes Institute	Orlando	Florida
United States	Advanced Gastroenterology Associates, LLC	Palm Harbor	Florida
United States	Stanford University	Palo Alto	California
United States	California Liver Research Institute	Pasadena	California
United States	St. Christopher's Hospital for Children	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic	Phoenix	Arizona
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	Bon Secours Liver Institute of Virginia	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, Davis	Sacramento	California
United States	Saint Louis University - Gastroenterology and Hepatology, Clinical Research Unit	Saint Louis	Missouri
United States	Silicon Valley Research Institute	San Jose	California
United States	University of Washington	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	NorthShore University HealthSystem	Skokie	Illinois
United States	Tampa General Medical Group	Tampa	Florida
United States	Medstar Georgetown Transplant Institute	Washington	District of Columbia
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Target PharmaSolutions, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Examine liver histology		10 years
Primary	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
Primary	Evaluate the impact of NASH therapies on medical co-morbidities		10 years