Evaluation of Patients With Liver Disease

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Jan 18, 2000

Keywords

ClinConnect Summary

This clinical trial is focused on understanding liver diseases, including Hepatitis D, C, and B, as well as other liver conditions. The study aims to evaluate and monitor patients who have acute or chronic liver disease. If you decide to participate, you'll start with a routine check-up where you'll provide blood and urine samples and have an ultrasound of your liver, which uses sound waves to create images of the liver's size and texture. After the initial visit, you'll need to return for check-ups once a year.

To be eligible for the study, you need to be at least 2 years old and either have signs of liver disease or be at risk for it. Healthy volunteers must be at least 18 years old and in good health. Throughout the study, additional tests may be needed, and these will be discussed with you beforehand. If you qualify, there may also be opportunities to receive medications that are currently being tested. Your participation could help advance research on liver diseases and potentially improve treatment options for others.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Affected Subjects
• In order to be eligible to participate in this study, an affected participant must meet all of the following criteria:
• • 1. \>=2 years of age.
• 2. Meets one of the following:
• • 1. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR
• • 2. At risk for acute or chronic liver disease
• • Healthy Volunteers
• In order to be eligible to participate in this study, a healthy volunteer must meet all of the following criteria:
• • 1. \>= 18 years of age.
• • 2. In good general health as evidenced by medical history
• EXCLUSION CRITERIA:
• • Affected Participants
• An affected participant who meets any of the following criteria will be excluded from participation in this study:
• • 1. History of significant medical illnesses that might interfere with prolonged follow up evaluation
• • Healthy Volunteers
• A healthy volunteer who meets any of the following criteria will be excluded from participation in this study:
• • 1. Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases
• • 2. Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)
• • 3. Average alcohol consumption \> 1 drink/day in past 6 months, per self-report
• • 4. History of liver disease (with the exception of neonatal jaundice)
• • 5. History of severe illness, infection or major surgery in the past year
• • 6. History of cancer (with the exception of basal cell carcinoma resected \> 1 year prior to enrollment)
• • 7. BMI \< 18 or BMI \>25
• • 8. Hemoglobin \< 11 (women) or hemoglobin \< 12 (men)
• • 9. ALT \>35 (men) or ALT \>25 (women)
• • 10. Alkaline Phosphatase \>= 150
• • 11. Bilirubin \>2 g/dL
• • 12. HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive
• • 13. Pregnancy
• • 14. Inability to provide informed consent

Trial Officials