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Prospective Study

A Multi-center, Longitudinal Study of Drug- and CAM-induced Liver Injury

Purpose | Liver Injury | Participate | Benefits | Procedures | Download PDF

Purpose

The purpose of this study is to try to understand the reasons why some people have unwanted liver reactions after taking certain drugs and herbal medicines (also called complementary and alternative medications [CAM]), while other people do not. There are 5 sites participating in the Drug-induced Liver Injury Network, which is sponsored by the National Institute of Diabetes & Digestive & Kidney Diseases, a component of the U.S. National Institutes of Health (NIH).

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Liver Injury due to Drugs—A Serious Concern

Liver injury is the main reason drugs do not get approved by the U.S. Food and Drug Administration or get removed from the market after initial approval. In addition, there are increasing reports of liver injury due to taking various nonprescription herbal medicines. Through the participation of yourself and others like you, we hope to be able to discover why some people have unwanted liver reactions to certain drugs and others do not. We are studying people who took the drugs in question. Some of these people ("cases") developed an unwanted liver reaction to these drugs, while the others ("controls") did not. We will look for genetic, environmental, and medical differences between the 2 groups of people so that we can understand the reasons why these reactions occur.

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Voluntary Participation

Your participation is entirely voluntary and will not cost you anything. You will receive a nominal fee to cover any expenses associated with the study and to compensate you for your effort. Your identity and research records will be kept confidential; your name will not be on the biological samples you give, and any results of research tests will not go into your medical records.

Things you might start thinking about . . .

You will be asked for the following information:

• Date you started taking the medication that may have caused a liver problem
• Other drugs and herbal medicines you were taking and when
• Your medical history
• Any family history of liver problems
• Your smoking and alcohol-use history

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Benefits to You and Others

Potential indirect benefits from participating in this study include the satisfaction of knowing that you have contributed in an important way to medical research that may benefit others in the future. If we are able to discover why people have unwanted reactions to drugs, we may be able to test people before giving them medications and prevent these reactions. It may also make it possible to design safer drugs in the future.

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The Study Will Proceed as Follows:

1. A member of the study team will review the consent and release-of-medical-information forms with you in person. You will have the opportunity to ask any questions you may have about the study. If you are still interested in participating, you will be asked to sign the forms.
2. You will then have a physical exam, answer questions about your medical history, etc., and complete questionnaires about your quality of life and current symptoms.
3. You will have blood drawn (for genetics research studies) and a urine sample collected.
4. "Control" subjects will have just 1 study visit. The "cases" will also have similar study visits at 6, 12, and 24 months after the first visit.
5. Some cases will be asked to have a liver ultrasound performed or, if one has been performed in the past, agree to have the results released to the study team.
6. You will be contacted (usually by mail) each year for several years and asked to update your contact information. This follow-up is important to learn about the long-term effects of the liver reaction and for possible enrollment into future studies.

Remember that you may withdraw from the study at any time and request that your blood sample be destroyed.

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