Bethesda, Maryland 20892

  • Liver Disease

Purpose:

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.


Study summary:

Study Description: This is a clinical research protocol to allow for collection of samples and data obtained during clinical evaluation and long-term follow up of patients who have an acute or chronic liver disease. The protocol is designed to create a repository 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. Samples collected during the course of clinical care for patients with liver disease include blood, saliva, urine, stool, and residual tissue obtained during clinically-indicated liver biopsies not otherwise needed for clinical care. Additionally, subjects with liver disease will be asked to provide a blood sample for genetic analysis. Healthy volunteers will be recruited and asked to provide a blood sample to serve as controls for the genetic analyses. Research will be conducted to investigate genetic factors that may contribute to liver diseases Objectives: Primary Objective To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of liver diseases Secondary Objective To determine if genetic factors may contribute to the susceptibility, progression, outcome, or treatment success of different liver diseases.


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


NCT ID:

NCT00001971


Primary Contact:

Principal Investigator
T. Jake Liang, M.D.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Patricia E Alcivar
Phone: (301) 435-6121
Email: patricia.alcivar@nih.gov


Backup Contact:

Email: jakel@mail.nih.gov
T. Jake Liang, M.D.
Phone: (301) 496-1721


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 27, 2022

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