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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
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Patients With Liver Disease
Actual Study Start Date : May 27, 1992

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Group/Cohort
Healthy individuals
Healthy individuals who have recovered from liver diseases or who are healthy volunteers
Patients
Liver disease patients



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study 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.
Criteria
  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Stated willingness to comply with all study procedures and availability for the duration of the study
  2. Male or female, >=2 years of age.
  3. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), healthcare organization or study subject.
  4. Absence of other significant medical illnesses that might interfere with prolonged follow up evaluation.
  5. Ability of subject, parent/guardian or Legally Authorized Representative to understand and the willingness to sign a written informed consent document.

EXCLUSION CRITERIA:

There are no specific reasons to exclude any patients from this protocol as it does not entail sig- nificant risk to the patient or excessive clinical burden to the Liver Diseases Branch. Patients who resolve their chronic liver disease, such as patients with chronic hepatitis B who become negative for HBsAg or patients with chronic hepatitis C who become negative for HCV RNA will continue to be followed despite lack of apparent disease or disability. This is to document that clearance of these hepatitis viruses is, indeed, associated with resolution of the liver disease and lack of long-term adverse effects. Because there are data suggesting that chronic HBsAg carriers who become HBsAg-negative and patients with chronic hepatitis C whose liver disease becomes inactive can still develop long-term consequences of these diseases (especially hepatocellular carcinoma), following such patients is important.

Adults only may have the following research tests but must meet certain criteria to have these research procedures:

Genetic Analysis of Serum Samples:

  • Adult subjects with clinically significant anemia will be excluded for phlebotomy that is necessary for isolation of DNA material from the blood cells.
  • Inability to understand or sign informed consent will also exclude patients from this aspect of the study

Apheresis:

  • Adult subjects will have to fulfill the criteria of the NIH Department of Transfusion Medicine regarding leukapheresis and plasmapheresis donors.
  • Because this is a research procedure to obtain reagents and assay materials, only patients who are active and relatively fit (i.e. not disabled from their liver disease) and do not exhibit any contraindications for the procedure will be asked to undergo this procedure.
  • Subject s <18 years old are excluded from apheresis.
  • Decisionally impaired adults are excluded from apheresis.
  • Pregnant women are excluded from apheresis procedures.

Information from the National Library of Medicine

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


Contacts
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Contact: Patricia E Alcivar (301) 435-6121 patricia.alcivar@nih.gov
Contact: T. Jake Liang, M.D. (301) 496-1721 jakel@mail.nih.gov

Locations
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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    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: T. Jake Liang, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00001971    
Other Study ID Numbers: 910214
91-DK-0214
First Posted: January 19, 2000    Key Record Dates
Last Update Posted: September 24, 2021
Last Verified: July 28, 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Hepatitis B
Hepatitis C
Hepatitis D
Chronic Hepatitis
Liver Disease
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis D
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections