Evaluation of Patients With Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-100
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
>=2 years of age.
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
>= 18 years of age.
Disqualifiers
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)
Trial population
This is a general clinical research protocol to allow for evaluation, investigation and long-term follow up of patients who have an acute or chronic liver disease. The protocol is designed to study the natural history and pathogenesis of various liver diseases such as acute and chronic hepatitis B, C, D and E, primary biliary cirrhosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, nonalcoholic steatohepatitis (NASH), noncirrhotic portal hypertension, hepatocellular carcinoma, and cryptogenic or poorly defined forms of chronic liver disease.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
8,050 Participants
are grouped into 2 trial groupsGroup A: Healthy individuals
Group B: Patients
Trial outcomes
Primary outcomes
1
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
Time frame
Annual visitsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov