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Protocol Details

Idiosyncratic Liver Injury Associated with Drugs (ILIAD): A Retrospective Study

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-DK-0143

Sponsoring Institute

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: n/a

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Drug Metabolism;
Liver Disease;
Hepatitis;
Toxicity

Recruitment Keyword(s)

None

Condition(s)

Liver Disease;
Drug-Induced Liver Injury

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Diabetes and Digestive and Kidney Diseases

Background:

Side effects of some drugs can injure the liver. This can lead to health problems and even death. Some people have liver injury after they take certain drugs or herbal or dietary supplements, while others do not. Researchers want to learn more about drug-induced liver injury. They also want to learn who is at greater risk for it. This may help doctors make better decisions about prescribing medicines. It could also help people avoid the use of drugs that may harm the liver.

Objectives:

To collect medical data and specimens from people who were affected by drug-induced liver injury for future research. To understand why some people are more susceptible to liver reactions to certain drugs.

Eligibility:

People ages 18 and older who took a drug or agent that may have caused liver injury that occurred since January 1994

Design:

Participants will allow access to their medical history and records.

Participants will answer questions about:

Their medical and medication history

Their alcohol use

Their liver problem

Participants will give blood and urine samples.

Participants who had a liver biopsy as part of their clinical care may be asked to allow access to some of the sample.

Samples will be used for genetic testing.

Participants may be able to join future studies.

Participants will be contacted each year for up to 20 years to update their contact data.

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Eligibility

INCLUSION CRITERIA:

1. 18 years and older

2. Evidence of liver injury that is known or suspected to be related to consumption of a drug or HDS product that occurred on or after January 1994.

3. Written informed consent from patient or patient s legal guardian.

4. Documented clinically important DILI, defined as any of the following:

a. ALT or AST >5x ULN or ALP >2x ULN confirmed on at least 2 consecutive blood draws in patients with previously normal values.

b. If baseline ALT, AST, or ALP are known to be elevated, then ALT or AST >5x baseline or ALP >2x baseline on at least 2 consecutive blood draws. Baseline is average of at least 2 measurements performed during 12-month period prior to starting implicated medication.

c. Any elevation of ALT, ALP, or AST associated with (a) increased total bilirubin (greater than or equal to 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:

1. Patients with any of the following will not be eligible

a. Competing cause of acute liver injury such as hepatic ischemia that is felt by the investigator to be primary reason for observed liver injury and supported by laboratory tests, serologies, liver biopsy or radiology.

b. Known, pre-existing autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease that may confound ability to make a diagnosis of DILI.

c. Acetaminophen toxicity.

d. Liver/allogenic bone marrow transplant prior to development of drug- or CAM-induced liver injury.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Christopher Koh, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)



Anna L. Rivero
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health
Building 10
Room 4-5722
10 Center Drive
Bethesda, Maryland 20892
(301) 451-7007
anna.rivero@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00360646

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