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Evaluation of Patients With Liver Disease
This study is currently Recruiting
February 2011 By National Institutes of Health Clinical Center (CC)
First Recieved on July 12, 2006
Last Updated on February 24, 2011
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
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.
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
|Ages Eligible for Study:||2 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
- 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
Absence of other significant medical illnesses that might interfere with prolonged follow
Willingness to enter the study.
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: Patients will have to fulfill the criteria of the NIH
Department of Transfusion Medicine regarding lymphapheresis donors. These include age
(less that 65 years), weight (greater than 120 pounds), hematocrit (greater than 30
percent), blood pressure (less than 120 diastolic and greater than 90 systolic), and
temperature (less than 37.5 degrees C). 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) will be asked to undergo this procedure.
The only strict exclusion criterion will be active therapy with interferon. The basis for
this exclusion was the findings from a retrospective analysis of a recent trial of
recombinant human alpha interferon as therapy of chronic hepatitis B. In that study, the
"response rate" or rate of clearance of hepatitis B virus with alpha interferon therapy
was lower among patients who underwent lymphapheresis during therapy (48 percent) (p less
than .01). Lymphapheresis performed before treatment did not seem to affect the outcome
of interferon therapy. These findings were unexpected but have led us to avoid both
plasmapheresis and lymphapheresis in patients receiving alpha interferon therapy. The
reasons why lymphapheresis might interfere with a response to alpha interferon are to
known, but probably relate to the importance of an intact, healthy immune system in the
process of recovery from a chronic viral infection.
Fibroscan: Consecutive adult patients (ages 18 or older) with chronic liver disease who
have had a liver biopsy performed within the previous 6 months or who are scheduled to
undergo liver biopsy will be eligible for participation in this aspect of the study.
Patients with liver biopsies that are inadequate for histological scoring or who have
ascites will be excluded from this aspect of the study.
Genetic Analysis of Serum Samples: All adult subjects with a Hct of less than 30 and
pediatric subjects with a Hct less than 26 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.