No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 100
Sex
Any
Study type
Observational
Participants needed
8,050 (estimated)
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
Who this trial is looking for
This trial is looking for patients with liver disease or healthy volunteers. Participants will have routine check-ups, give blood and urine samples, and undergo a liver ultrasound.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 2 years old.
I have liver disease or am at risk for it.
I am at least 18 years old and in good general health.
You may not be able to join if
I have significant medical illnesses that could interfere with follow-up.
I have a chronic medical condition like heart, kidney, or lung diseases.
I take regular medications or supplements (except multivitamins or birth control).
I have consumed more than 1 drink a day on average in the past 6 months.
I have a history of liver disease (except neonatal jaundice).
I had a severe illness, infection, or major surgery in the past year.
I have a history of cancer (except basal cell carcinoma removed over a year ago).
I cannot provide informed consent.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 liv…
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.
Trial Locations
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State
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Status
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 ref…
* 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
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