Drug-Induced Liver Injury (DILI) Network Retrospective

Launched by DUKE UNIVERSITY · Aug 2, 2006

Keywords

ClinConnect Summary

The Drug-Induced Liver Injury (DILI) Network Retrospective trial is studying patients who have experienced liver damage caused by medications or certain health products. The aim is to gather important information and biological samples, like blood and DNA, from these individuals to help researchers understand why some people react severely to drugs in this way. This study will create a database that includes details about each patient's experience with drug-induced liver injury, which can be used in future research.

To be eligible for the study, participants must be at least 2 years old and have a healthcare provider who believes they have suffered from drug-induced liver injury since January 1, 1994. Participants need to be alive and have taken only one relevant medication before their liver injury occurred. The study will involve providing medical information and blood samples, but those who cannot give informed consent or have other liver conditions may not be able to participate. Being part of this trial will not only contribute to valuable research but also help improve understanding and treatment of drug-induced liver injuries in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Screening Criteria
• To be included in the ILIAD registry, the following criteria must be satisfied:
• • The treating gastroenterologist / hepatologist or health care professional must believe that the subject suffered drug-induced liver injury;
• • The subject must be alive and the date of onset of the qualifying DILI episode must have occurred on or after January 1, 1994;
• • Evidence of injury that is known or suspected to be related to consumption of a drug or HDS/CAM product
• • The subject is taking only one of these drugs or HDS agent(s) in the period leading up to the onset of the qualifying DILI episode;
• • Have clinically important DILI defined in terms of serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (Alk Phos).
• • Sufficient documentation of the event for the Causality Committee to make a determination.
• Exclusion Criteria:
• Subjects will be excluded according to the following criteria:
• • are not willing to have medical information and blood samples taken;
• • are unable to adequately give informed consent to participate in the study including the blood draw for the genetic component;
• • age \< 2 years old at the time of study enrollment (due to blood volume requirements).
• • Have a competing cause of liver injury such as hepatic ischemia that the investigator felt to be the primary reason for the observed liver injury. Known, pre-existing autoimmune hepatitis; primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease. Subjects are excluded due to acetaminophen hepatoxicity or liver transplant or allogeneic bone marrow transplant prior to development of drug-CAM induced liver injury.