[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07060547":3,"trial-entities:NCT07060547":75,"trial-summary:NCT07060547":79},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":16,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":31,"secondary_outcomes":36,"sex":37,"minimum_age":38,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":39,"std_ages":49,"locations":52,"central_contacts":71,"overall_officials":72,"references":73,"see_also_links":74},"NCT07060547","Stanford 78916","Investigating HepQuant DuO Test as a Biomarker in Alcohol-related Liver Disease","RECRUITING","2032-03","2025-07","2025-07-11","2025-06-10","HepQuant, LLC","INDUSTRY",false,"This is a study to measure liver recovery in patients with recent alcohol-associated liver injury by assessing liver function and physiology using HepQuant DuO. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and 2 blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data to better monitor and treat patients who have been affected by alcohol-associated liver disease. The study has 4 visits at an outpatient clinic at 1, 3, 6, and 12 months. At each of these visits, participants will undergo a HepQuant DuO test and other standard tests. In addition, the study team will ask about a participant's alcohol use, symptoms, and quality of life.",null,[18,19],"Alcoholic Hepatitis","Alcohol-related Liver Disease",[],"OBSERVATIONAL",[],{"count":24,"type":25},40,"ESTIMATED",[27],{"type":28,"name":29,"description":30},"DEVICE","HepQuant DuO Test","HepQuant DuO is commercially available in the U.S. as a Laboratory Developed Test (LDT), but it will be used in this study as a nonsignificant risk investigational device to measure change in liver function over time.",[32],{"measure":33,"description":34,"timeFrame":35},"Change in HepQuant Disease Severity Index (DSI) over time in patients with ALD","The objective of use of the HepQuant DuO test in this study is to evaluate how the HepQuant Disease Severity Index (DSI) changes over time in patients with alcohol-related liver disease (ALD) and to define the relationships of change in HepQuant DSI (ΔDSI) to the changes in the standard of care laboratory and imaging tests used for measuring severity of liver disease and clinical outcomes. The HepQuant DSI is a value on a scale of 0 to 50, where 0 indicates no liver disease and 50 indicates severe liver disease.","From enrollment to 1 year past enrollment",[],"ALL","18 Years",{"inclusion":40,"exclusion":42,"raw_text":48},[41],"adult with a clinical diagnosis of liver disease due to alcohol who have acute hepatic decompensation.",[43,44,45,46,47],"Clinical diagnosis of liver disease with an etiology other than alcohol liver disease unless it is a combined clinical diagnosis of ALD and NASH.","patients with solid organ malignancy.","patients with other disease affecting the liver including autoimmune, drug-related liver injury, hemochromatosis or Wilson's disease","pregnancy","under the age of 18","Inclusion Criteria:\n\n* adult with a clinical diagnosis of liver disease due to alcohol who have acute hepatic decompensation.\n\nadult with a combined clinical diagnosis of alcohol-related liver disease (ALD) and nonalcoholic steatohepatitis (NASH).\n\nExclusion Criteria:\n\n* Clinical diagnosis of liver disease with an etiology other than alcohol liver disease unless it is a combined clinical diagnosis of ALD and NASH.\n* patients with solid organ malignancy.\n* patients with other disease affecting the liver including autoimmune, drug-related liver injury, hemochromatosis or Wilson's disease\n* pregnancy\n* under the age of 18",[50,51],"ADULT","OLDER_ADULT",[53],{"facility":54,"status":7,"city":55,"state":56,"zip":57,"country":58,"contacts":59,"geoPoint":68},"Stanford University Dept. of Medicine -Gastroenterology & Hepatology","Redwood City","California","94063","United States",[60,65],{"name":61,"role":62,"phone":63,"email":64},"Ethan Assistant Clinical Research Coordinating Associate, BA","CONTACT","650-460-6119","eakamaga@stanford.edu",{"name":66,"role":67},"Allison Kwong, MD","PRINCIPAL_INVESTIGATOR",{"lat":69,"lon":70},37.48522,-122.23635,[],[],[],[],{"nct_id":4,"conditions":76,"biomarkers":78},[18,19,77],"Nonalcoholic Steatohepatitis",[],{"nct_id":4,"found":80,"summary":81,"prompt_version":91},true,{"design":82,"status":83,"heading":84,"summary":85,"follow_up":86,"word_count":87,"commitments":88,"compensation":89,"drugs_mentioned":90},"This is an observational study with 40 planned participants. It is not specified if it is randomized or blinded.","completed","Investigating HepQuant DuO Test for Alcohol-related Liver Disease","This study is looking at how well the HepQuant DuO Test can measure liver recovery in people with liver damage caused by alcohol. The HepQuant DuO Test is a blood test that involves drinking a natural compound called cholate and then having two blood samples taken. Researchers want to see how the HepQuant DuO Test's Disease Severity Index (DSI) changes over one year. You might be able to join if you are an adult with a liver disease diagnosis due to alcohol, especially if you have acute hepatic decompensation (a sudden worsening of liver function) or a combination of alcohol-related liver disease and nonalcoholic steatohepatitis (NASH). The study is currently recruiting 40 participants.","Participants will be followed for one year after enrollment to measure changes in the HepQuant Disease Severity Index (DSI).",113,"You would have 4 outpatient clinic visits over one year (at 1, 3, 6, and 12 months). At each visit, you will have a HepQuant DuO test, other standard tests, and answer questions about your alcohol use, symptoms, and quality of life.","Not stated in the trial record.",[29],"v2"]