Brief Title
Evaluation of Patients With Liver Disease
Official Title
Evaluation of Patients With Liver Disease
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.
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 blood and
urine tests and abdominal ultrasound. Patients will then be followed in the outpatient
department at intervals appropriate for their clinical status, 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. 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.
Study Type
Observational
Primary Outcome
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
Condition
Hepatitis D
Study Arms / Comparison Groups
Healthy individuals
Description: Healthy individuals who have recovered from liver diseases or who are healthy volunteers
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
8000
Start Date
May 27, 1992
Eligibility Criteria
- INCLUSION CRITERIA:
An indefinite number of patients with acute or chronic liver disease will be enrolled in
this study. Criteria for selection will be the following:
Age above 2 years, male or female.
Evidence of acute or chronic liver disease on evaluation by the outside referring
physician.
Absence of other significant medical illnesses that might interfere with prolonged follow
up evaluation.
Willingness to enter the study.
EXCLUSION CRITERIA:
There are no specific reasons to exclude any patients from this protocol (exception below
for plasmapheresis and lymphapheresis, and genetic analysis of serum samples) as it does
not entail significant 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.
Plasmapheresis and lymphapheresis:Adult patients will have to fulfill the criteria of the
NIH Department of Transfusion Medicine regarding lymphopheresis 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.
The only strict
exclusion criteria for plasmapheresis and lymphapheresis will be patient age (<18 years
old).
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.
Gender
All
Ages
2 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
T. Jake Liang, M.D., (301) 451-6983, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00001971
Organization ID
910214
Secondary IDs
91-DK-0214
Responsible Party
Sponsor
Study Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor
T. Jake Liang, M.D., Principal Investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date
November 10, 2020