Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium
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|ClinicalTrials.gov Identifier: NCT02172898|
Recruitment Status : Active, not recruiting
First Posted : June 24, 2014
Last Update Posted : August 7, 2018
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||1260 participants|
|Official Title:||Alcoholic Hepatitis: A Multicenter, Observational Study by the TREAT Consortium|
|Actual Study Start Date :||June 2013|
|Actual Primary Completion Date :||June 29, 2018|
|Estimated Study Completion Date :||July 2019|
Heavily Drinking Controls
Heavy alcohol drinking will be defined as > 40 grams per day on average in women and > 60 grams per day on average in men for a minimum of 6 months and within the 6 weeks prior to study enrollment. Heavy drinkers, who have just become abstinent within prior 2 weeks, including those we convince to seek treatment as part of the recruiting process, are eligible for enrollment. Control subjects must meet the following criteria: (1) AST, ALT, and total bilirubin levels must be within normal range; (2) no prior history of known alcoholic liver disease; and (3) absence of hepatosplenomegaly (from physical examination or radiographic imaging) or stigmata of liver disease.
Subjects with AH
Diagnosis of AH will be established on published criteria based on history of heavy alcohol consumption (defined as > 40 grams per day on average in women and > 60 grams per day on average for men for a minimum of 6 months and within the 6 weeks prior to study enrollment), clinical evaluation and appropriate laboratory testing (as defined as total bilirubin > 2 mg/dL and AST > 50 U/L). When diagnosis of AH remains in question, a liver biopsy (if clinically feasible and subject has no contraindications) will be required. We plan to enroll patients with AH in special population infected with hepatitis B (HBV), hepatitis C (HCV), or HIV.
- Developing a repository of biological samples from AH patients and heavy drinking controls. [ Time Frame: Up to 1 year ]To conduct a prospective, multicenter, observational study of patients with well-characterized AH and frequency matched individuals (by age, gender, and race) with comparable history of alcohol consumption but no clinical evidence of liver disease (controls). At the end of the study, a robust clinical information, central bio-repository of serum/plasma, peripheral mononuclear cells, genomic DNA, stool samples, urine, and liver tissue (where available) will be developed from both cases and controls.
- Characterizing AH subjects and controls to serve as the foundation for novel mechanistic and therapeutic studies. [ Time Frame: Up to 1 year ]
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): NCT02172898
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Naga Chalasani, MD||Indiana University|