Evaluation of Patients With Liver Disease
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.
Biliary Liver Cirrhosis,
|Official Title:||Evaluation of Patients With Liver Disease|
|Study Start Date:||September 1991|
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. Patients will initially be seen in the outpatient department and undergo a medical history and physical examination. They will have a series of blood and urine tests and abdominal ultrasound. Patients will then be followed in the outpatient department with visits every 1 to 12 months at which times they will undergo an interim medical history and brief examination and have blood studies taken. Liver biopsies will be done as a part of this protocol only if clinically indicated, and a separate consent form is provided. In addition, patients may be asked to undergo skin biopsy, plasmapheresis, lymphapheresis, genetic analysis, and Fibroscan procedures for research purposes only (immunologic, virologic, genetic, and other studies) and separate consent forms are provided. Patients qualifying for therapeutic or other trials of antiviral or immunomodulatory agents for their liver disease will be invited to enter such studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001971
|Contact: Nancy Fryzek||(301) firstname.lastname@example.org|
|Contact: T. Jake Liang, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||T. Jake Liang, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|