A Longitudinal Observational Study of Patients With Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD)
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| ClinicalTrials.gov Identifier: NCT02815891 |
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Recruitment Status :
Recruiting
First Posted : June 28, 2016
Last Update Posted : October 15, 2021
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Sponsor:
Target PharmaSolutions, Inc.
Information provided by (Responsible Party):
Target PharmaSolutions, Inc.
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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.
| Condition or disease |
|---|
| Nonalcoholic Fatty Liver Nonalcoholic Steatohepatitis |
| Study Type : | Observational [Patient Registry] |
| Estimated Enrollment : | 15000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 5 Years |
| 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) |
| Study Start Date : | July 2016 |
| Estimated Primary Completion Date : | July 2036 |
| Estimated Study Completion Date : | July 2036 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Non-alcoholic fatty liver disease
Primary Outcome Measures :
- Establish an understanding of the current natural history of NASH at academic and community medical centers [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 years ]
- Estimate adverse event frequency and severity and describe management practices [ Time Frame: 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 [ Time Frame: 10 years ]
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.
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| Ages Eligible for Study: | 2 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Adults and children with NAFL or NASH who are being seen specifically to address this disease process
Criteria
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.
Information from the National Library of Medicine
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
Contacts
| Contact: Jonathan Durlam, MPH | jdurlam@targetrwe.com |
Locations
Show 74 study locations
Sponsors and Collaborators
Target PharmaSolutions, Inc.
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Target PharmaSolutions, Inc. |
| ClinicalTrials.gov Identifier: | NCT02815891 |
| Other Study ID Numbers: |
TARGET-NASH |
| First Posted: | June 28, 2016 Key Record Dates |
| Last Update Posted: | October 15, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Liver Diseases Fatty Liver Non-alcoholic Fatty Liver Disease Digestive System Diseases |