Drug-Induced Liver Injury
Idiosyncratic Liver Injury Associated with Drugs (ILIAD)
The goal of the ILIAD protocol is to create a database and bank of biological specimens (DNA, plasma, lymphocytes) from individuals with severe drug-induced liver injury (DILI) due to isoniazid (INH), phenytoin (Dilantin), amoxicillin/clavulanate (Augmentin), or valproic acid (Depakote) after January 1, 1994. This study is funded by the NIH/NIDDK.
Inclusion Criteria
- The suspect medication is isoniazid, phenytoin, amoxicillin/clavulanate, or valproic acid
- For INH, phenytoin, or amoxicillin/clavulanate, peak total serum bilirubin ≥2.5 mg/dL
- For valproic acid, clinical presentation severe enough to prompt hospitalization with evidence of liver injury (INR >1.5, serum ALT >3 x ULN, or characteristic liver biopsy)
- DILI episode after January 1, 1994
Exclusion Criteria
- Age <2 years at enrollment
Study Design
- Telephone or personal interview of medical history surrounding DILI event
- Single blood draw
- Participant receives $75
Please contact Suzanne Welch at 734-936-4886, toll free 1-866-UM-LIVER, or Robert Fontana, MD, for referrals or questions.
For more information, see the following web sites:
Drug-Induced Liver Injury Network
NIH funds network to study drug-induced liver injury
Press Release: U-M helps lead national study of liver damage
1-866-UM-LIVER
swelc@med.umich.edu
A Multicenter, Longitudinal Study of Drug-Induced and Complementary and Alternative Medication-Induced Liver Injury
The goal of this NIH study is to prospectively identify bona fide cases of liver injury due to drugs and complementary and alternative medications (CAM) within 6 months of onset. Clinical data, blood, DNA, and urine will be collected from affected patients and matched controls for mechanistic and genetic studies.
Inclusion criteria
- Age >2 years
- Liver injury known or suspected to be related to a drug or CAM product in the 6 months prior to enrollment
- Clinically important DILI, which is defined as:
—ALT or AST > 5 x ULN or Alk Phos > 2 x ULN confirmed on at least 2 consecutive blood draws in patients with previously normal values
—If baseline (BL) ALT, AST, or Alk Phos are elevated, ALT or AST > 5 x BL or Alk Phos > 2 x BL on at least 2 consecutive blood draws
—Any elevation in ALT, Alk Phos, or AST associated with total bilirubin ≥ 2.5 mg/dL in absence of liver disease, Gilbert syndrome, hemolysis - For liver disease cases, established chronic hepatitis B or C infections for > 6 months prior to DILI onset.
Exclusion Criteria
- Competing cause of acute liver injury such as hepatic ischemia or acetaminophen overdose or pre-existing autoimmune hepatitis, PBC, or PSC which may confound the ability to diagnose DILI.
- Liver transplant prior to DILI onset.
Study Design
- All subjects have a baseline and 6-month follow-up visit at the General Clinical Research Center, which includes surveys, medical history, blood and urine collection.
- Patients with liver injury at 6 months return for 12- and 24-month visits.
Costs
- Costs of study lab tests provided by sponsor (NIDDK).
- Subjects receive $50 for each completed study visit.
Please contact Suzanne Welch at 734-936-4886, toll free 1-866-UM-LIVER, or Robert Fontana, MD for referrals or questions.
For more information, see the following web sites:
Drug-Induced Liver Injury Network
NIH funds network to study drug-induced liver injury
Press Release: U-M helps lead national study of liver damage
1-866-UM-LIVER
swelc@med.umich.edu
