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A Multi-center, Longitudinal Study of Drug- and CAM-induced Liver Injury
Background | Study Protocol | Eligibility Criteria | How you can Help | Objectives | Download Brochure PDF
Background
Drug-induced liver injury (DILI) is the most common reason for regulatory actions concerning drugs in development and in clinical practice. Fortunately, severe DILI leading to jaundice is an infrequent event, with an annual incidence ranging from 1 in 10,000 to 1 in 1,000,000 prescription-years. The idiosyncratic nature of DILI plus its low incidence has hampered our ability to identify clinical, environmental, and genetic susceptibility factors. As a result, there is a great need to improve our detection, definition, and understanding of the mechanism of DILI.
To stimulate research, the NIDDK has established the Drug-Induced Liver Injury Network to conduct controlled, clinical studies into DILI.
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Study Protocol
- Informed consent is obtained.
- Participant data are collected during a visit to a DILIN clinical site.
- Some information is collected directly from the participant; other data are abstracted from medical charts and records.
- Quality-of-life and other symptoms questionnaires are administered.
- Blood and urine samples are obtained.
- Liver ultrasound is performed, If not already done.
- Follow-up evaluation is completed at 6 months.
- Evaluations at 12 months and annually thereafter are completed for patients who satisfy the definition of chronic DILI.
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Eligibility Criteria
DILI Cases
Inclusion criteria:
- Adults or children > 2 years old
- Evidence of liver injury known or suspected to be related to a drug or CAM product when within the previous 6 months
- Written informed consent
- Documented clinically significant DILI, as shown by any of the following:
- Jaundice or serum bilirubin > 2.5 mg/dL and any elevation in ALT, AST, or alkaline phosphatase
- No jaundice and serum bilirubin < 2.5 mg/dL, but elevations in ALT or AST (> 5 x ULN) or elevations in alkaline phosphatase (> 2 x ULN)
- In persons with known pre-existing liver disease (such as chronic hepatitis B or C), elevations in ALT or AST > 5 x baseline values or elevations in alkaline phosphatase > 2 x baseline values
Exclusion criteria:
- Other known cause of acute liver injury, such as cholangitis, acute viral hepatitis, or autoimmune liver disease
- Acetaminophen hepatotoxicity
- Liver transplantation
If you have a patient that meets the criteria contact the DILIN clinical site that is nearest to you.
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How You can Help
We need your help with patient recruitment. If you have patients who are eligible, we want to hear from you.
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Study Objectives
Primary:
- Identify cases of DILI due to drugs and complementary and alternative medications (CAM), within 6 months of presentation
- Collect clinical data, blood, DNA, urine, and liver tissue samples from DILI cases and controls for future studies
Secondary:
- Identify clinical, immunological, and environmental risk factors for drug-mediated hepatotoxicity
- Identify genetic risk factors that may help explain variability in susceptibility and outcome of drug- and CAM-induced liver injury
- Characterize the natural history of drug- and CAM-induced liver injury for at least 6 months following enrollment
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