| NCT ID | NCT00345930 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Liver Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2004-09 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2004-09 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Huiman X. Barnhart, PhD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT00345930 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, studying Liver Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00345930 currently recruiting?
Yes, NCT00345930 is actively recruiting participants. Contact the research team at eilene.pham@duke.edu for enrollment information.
Where is the NCT00345930 trial being conducted?
This trial is being conducted at Los Angeles, United States, Indianapolis, United States, Bethesda, United States, Ann Arbor, United States and 2 additional locations.
Who is sponsoring the NCT00345930 clinical trial?
NCT00345930 is sponsored by Duke University. The principal investigator is Huiman X. Barnhart, PhD at Duke University. The trial plans to enroll 4,000 participants.