Evaluation of Patients With Liver Disease
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|ClinicalTrials.gov Identifier: NCT00001971|
Recruitment Status : Recruiting
First Posted : January 19, 2000
Last Update Posted : September 24, 2021
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....
|Condition or disease|
|Hepatitis D Hepatitis C Hepatitis B Liver Disease|
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 of clinical evaluation and the collection of research samples. Patients will then be followed in the outpatient department at intervals appropriate for their clinical status. At which patients will undergo an interim medical history and brief examination, with research samples collected. Collection of additional tissue biopsy may be obtained during a clinically indicated procedure such as liver biopsy.
Subjects may be asked to undergo leukapheresis or plasmapheresis, and genetic analysis for research purposes, and separate consent forms are provided. In addition, a control group of healthy volunteers will be recruited for genetic analysis, leukapheresis and plasmapheresis.
Subjects who qualify for other studies of their liver disease will be offered participation.
|Study Type :||Observational|
|Estimated Enrollment :||8000 participants|
|Official Title:||Evaluation of Patients With Liver Disease|
|Actual Study Start Date :||May 27, 1992|
Healthy individuals who have recovered from liver diseases or who are healthy volunteers
Liver disease patients
- Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response [ Time Frame: Annual visits ]Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001971
|Contact: Patricia E Alcivar||(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 Office of Patient Recruitment (OPR) 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)|