Evaluation of Patients With Liver Disease
Recruiting · NCT00001971 · Observational (researchers observe without assigning treatment) · Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
View the official record on ClinicalTrials.gov →What this trial is about
The proposed study aims to evaluate, investigate, and follow-up patients suffering from acute and chronic liver disease. The study will focus on understanding diseases affecting the liver. Patients participating in the study will first undergo a routine check-up as an outpatient. They will be asked to provide blood and urine samples for laboratory testing and will undergo an ultrasound of the liver. Ultrasound examinations use sound waves to determine the size and texture of the liver. After the initial visit subjects will be requested to follow-up once a year at the outpatient department for a similar check-up. Additional tests may be requested throughout the study to provide information for other research studies and individual consent will be requested. These tests may include liver biopsies, skin biopsies, and / or specialized blood, plasma, and lymphocyte examinations. Subjects that qualify for medications presently being studied may be offered the opportunity to benefit from experimental therapy....
Who can take part
Inclusion criteria
- Affected Subjects
- In order to be eligible to participate in this study, an affected participant must meet all of the following criteria:
- \>=2 years of age.
- Meets one of the following:
- Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR
- 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:
- \>= 18 years of age.
- 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:
- \. 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:
- Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases
- Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)
- Average alcohol consumption \> 1 drink/day in past 6 months, per self-report
- History of liver disease (with the exception of neonatal jaundice)
- History of severe illness, infection or major surgery in the past year
- History of cancer (with the exception of basal cell carcinoma resected \> 1 year prior to enrollment)
- BMI \< 18 or BMI \>25
- Hemoglobin \< 11 (women) or hemoglobin \< 12 (men)
- ALT \>35 (men) or ALT \>25 (women)
- Alkaline Phosphatase \>= 150
- Bilirubin \>2 g/dL
- HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive
- Pregnancy
- Inability to provide informed consent
Where it is running
1 location listed across 1 US state.
- National Institutes of Health Clinical Center - Bethesda, Maryland, United States