A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH)
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|ClinicalTrials.gov Identifier: NCT02815891|
Recruitment Status : Recruiting
First Posted : June 28, 2016
Last Update Posted : September 30, 2020
|Condition or disease|
|Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||15000 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH)|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2026|
|Estimated Study Completion Date :||July 2026|
- Establish an understanding of the current natural history of NASH at academic and community medical centers [ Time Frame: up to 5 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 [ Time Frame: up to 5 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 [ Time Frame: up to 5 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 [ Time Frame: up to 5 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 [ Time Frame: up to 5 years ]
- Estimate adverse event frequency and severity and describe management practices [ Time Frame: up to 5 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 [ Time Frame: up to 5 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02815891
|Contact: Jonathan Durlam, MPHfirstname.lastname@example.org|