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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, pager # 4742, or swelc@umich.edu or Robert Fontana rfontana@umich.edu or pager # 4820 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@umich.edu
A Multicenter, Longitudinal Study
of Drug- and CAM-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, 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’s, 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 GCRC 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, pager # 4742, or swelc@umich.edu or Robert Fontana rfontana@umich.edu or pager # 4820 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@umich.edu
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