Evaluation of Patients With Liver Disease
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00001971 |
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Recruitment Status :
Recruiting
First Posted : January 19, 2000
Last Update Posted : March 6, 2023
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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 |
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| Hepatitis D Hepatitis C Hepatitis B Liver Disease |
Study Description:
This is a clinical research protocol to allow for collection of samples and data obtained during clinical evaluation and long-term follow up of patients who have an acute or chronic liver disease. The protocol is designed to create a repository 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. Samples collected during the course of clinical care for patients with liver disease include blood, saliva, urine, stool, and residual tissue obtained during clinically-indicated liver biopsies not otherwise needed for clinical care. Additionally, subjects with liver disease will be asked to provide a blood sample for genetic analysis. Healthy volunteers will be recruited and asked to provide a blood sample to serve as controls for the genetic analyses. Research will be conducted to investigate genetic factors that may contribute to liver diseases
Objectives: Primary Objective
To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of liver diseases
Secondary Objective
To determine if genetic factors may contribute to the susceptibility, progression, outcome, or treatment success of different liver diseases.
| Study Type : | Observational |
| Estimated Enrollment : | 8050 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Evaluation of Patients With Liver Disease |
| Actual Study Start Date : | May 27, 1992 |
| Group/Cohort |
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Healthy individuals
Healthy individuals who have recovered from liver diseases or who are healthy volunteers
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Patients
Liver disease patients
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- 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
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.
| 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 |
- INCLUSION CRITERIA:
Affected Subjects
In order to be eligible to participate in this study, an affected participant must meet all of the following criteria:
- >=2 years of age.
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Meets one of the following:
- Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR
- At risk for acute or chronic liver disease
Healthy Volunteers
In order to be eligible to participate in this study, a healthy volunteer must meet all of the following criteria:
- >= 18 years of age.
- In good general health as evidenced by medical history
EXCLUSION CRITERIA:
Affected Participants
An affected participant who meets any of the following criteria will be excluded from participation in this study:
1. History of significant medical illnesses that might interfere with prolonged follow up evaluation
Healthy Volunteers
A healthy volunteer who meets any of the following criteria will be excluded from participation in this study:
- Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases
- Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)
- Average alcohol consumption > 1 drink/day in past 6 months, per self-report
- History of liver disease (with the exception of neonatal jaundice)
- History of severe illness, infection or major surgery in the past year
- History of cancer (with the exception of basal cell carcinoma resected > 1 year prior to enrollment)
- BMI < 18 or BMI >25
- Hemoglobin < 11 (women) or hemoglobin < 12 (men)
- ALT >35 (men) or ALT >25 (women)
- Alkaline Phosphatase >= 150
- Bilirubin >2 g/dL
- HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive
- Pregnancy
- Inability to provide informed consent
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) 435-6121 | patricia.alcivar@nih.gov | |
| Contact: T. Jake Liang, M.D. | (301) 496-1721 | jakel@mail.nih.gov |
| United States, Maryland | |
| National Institutes of Health Clinical Center | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Principal Investigator: | T. Jake Liang, M.D. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | March 6, 2023 |
| Last Verified: | February 28, 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hepatitis B Hepatitis C Hepatitis D |
Chronic Hepatitis Natural History Liver Disease |
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Hepatitis A Hepatitis C Hepatitis B Hepatitis D Hepatitis Hepatitis, Viral, Human Liver Diseases Digestive System Diseases Virus Diseases |
Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Hepadnaviridae Infections DNA Virus Infections |