Liver Diseases Clinical Trial
Official title:
A Multi-Center, Longitudinal Study of Drug-and CAM-Induced Liver Injury
Verified date | April 2024 |
Source | Duke University |
Contact | Eilene Pham |
Phone | 9196607253 |
eilene.pham[@]duke.edu | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to identify individuals who have suffered a liver injury arising as an idiosyncratic reaction to a prescription drug or a complementary and alternative medicine. Recently added acute cases enrollment that meets criteria to the protocol. Also added Fibroscans to the protocol that will be completed at baseline and follow-up on chronic subjects.
Status | Recruiting |
Enrollment | 4000 |
Est. completion date | July 31, 2028 |
Est. primary completion date | July 31, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years and older |
Eligibility | Inclusion Criteria: - Age > 2 years at enrollment into the study. - Evidence of liver injury that is known or suspected to be related to consumption of a drug or CAM product in the 6-month period prior to enrollment. - Written Informed consent from the patient or the patient's legal guardian. - Documented clinically important DILI, defined as any of the following: 1. ALT or AST >5 x ULN or A P'ase >2 x ULN confirmed on at least 2 consecutive blood draws in patients with previously normal values. 2. If baseline (BL) ALT, AST or A P'ase are known to be elevated, then ALT or AST >5 x BL or A P'ase >2 x BL on at least 2 consecutive blood draws. "Baseline" is defined as the average of at least 2 measurements performed during the 12-month period prior to starting the DILI medication. 3. Any elevation of ALT, A P'ase, or AST, associated with (a) increased total bilirubin [ = 2.5 mg/dL], in absence of prior diagnosis of liver disease, Gilbert's syndrome, or evidence of hemolysis or (b) coagulopathy with INR > 1.5 in absence of coumadin therapy or known vitamin K deficiency. Exclusion Criteria: Patients with any of the following will not be eligible for participation: - Competing cause of acute liver injury such as hepatic ischemia that is felt by the investigator to be the primary reason for observed liver injury and supported by laboratory tests, serologies, liver biopsy, or radiology. - Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease which may confound the ability to make a diagnosis of DILI. - Acetaminophen hepatotoxicity. - Liver/bone marrow transplant prior to the development of drug- or CAM-induced liver injury. |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | NIH Clinical Site | Bethesda | Maryland |
United States | Univeristy of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Indiana University | Indianapolis | Indiana |
United States | University of Southern California | Los Angeles | California |
United States | Icahn School of Medicine at Mount Sinai | New York | New York |
United States | Thomas Jefferson | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Duke University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Chalasani N, Fontana RJ, Bonkovsky HL, Watkins PB, Davern T, Serrano J, Yang H, Rochon J; Drug Induced Liver Injury Network (DILIN). Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology. 2008 Dec;135(6):1924-34, 1934.e1-4. doi: 10.1053/j.gastro.2008.09.011. Epub 2008 Sep 17. — View Citation
Fontana RJ, Watkins PB, Bonkovsky HL, Chalasani N, Davern T, Serrano J, Rochon J; DILIN Study Group. Drug-Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. Drug Saf. 2009;32(1):55-68. doi: 10.2165/00002018-200932010-00005. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Develop a database of recent DILI cases | develop a database of recent DILI cases | July 2028 |
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