A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
- Conditions
- Nonalcoholic Fatty LiverNonalcoholic Steatohepatitis
- Registration Number
- NCT02815891
- Lead Sponsor
- Target PharmaSolutions, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15000
- 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.
- Inability to provide informed assent/consent.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimate adverse event frequency and severity and describe management practices 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).
Evaluate the impact of NASH therapies on medical co-morbidities 10 years Establish an understanding of the current natural history of NASH at academic and community medical centers 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.
Evaluate NASH treatment regimens being used in clinical practice 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.
Examine populations underrepresented in phase II-III clinical trials 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.
Evaluate optimal duration and combination of NASH therapies to achieve clinical response and clinical remission 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.
Examine liver histology 10 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (74)
Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic
🇺🇸Phoenix, Arizona, United States
Stanford University
🇺🇸Palo Alto, California, United States
California Liver Research Institute
🇺🇸Pasadena, California, United States
University of California, Davis
🇺🇸Sacramento, California, United States
Silicon Valley Research Institute
🇺🇸San Jose, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Connecticut Gastroenterology
🇺🇸Hartford, Connecticut, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Medstar Georgetown Transplant Institute
🇺🇸Washington, District of Columbia, United States
Gastro Florida
🇺🇸Clearwater, Florida, United States
Scroll for more (64 remaining)Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic🇺🇸Phoenix, Arizona, United States