Evaluation of Patients With Liver Disease
|First Received Date ICMJE||July 12, 2006|
|Last Updated Date||November 11, 2014|
|Start Date ICMJE||September 1991|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001971 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of Patients With Liver Disease|
|Official Title ICMJE||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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||99999999|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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.
|Ages||2 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00001971|
|Other Study ID Numbers ICMJE||910214, 91-DK-0214|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )|
|Study Sponsor ICMJE||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||July 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP