This study is currently recruiting participants.
Number
91-DK-0214
Sponsoring Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Recruitment Detail
Type: Participants currently recruited/enrolled Gender: Male & Female Min Age: 2 Years Max Age: 100 Years
Referral Letter Required
Yes
Population Exclusion(s)
None
Keywords
Hepatitis B; Hepatitis C; Hepatitis D; Chronic Hepatitis; Natural History
Recruitment Keyword(s)
Liver Disease
Condition(s)
Hepatitis D; Hepatitis C; Hepatitis B; Liver Disease
Investigational Drug(s)
Investigational Device(s)
Intervention(s)
Supporting Site
National Institute of Diabetes and Digestive and Kidney Diseases
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.
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INCLUSION CRITERIA: Affected Subjects In order to be eligible to participate in this study, an affected participant must meet all of the following criteria: 1. >=2 years of age. 2. Meets one of the following: a. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR b. 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: 1. >= 18 years of age. 2. 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: 1. Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases 2. Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives) 3. Average alcohol consumption > 1 drink/day in past 6 months, per self-report 4. History of liver disease (with the exception of neonatal jaundice) 5. History of severe illness, infection or major surgery in the past year 6. History of cancer (with the exception of basal cell carcinoma resected > 1 year prior to enrollment) 7. BMI < 18 or BMI >25 8. Hemoglobin < 11 (women) or hemoglobin < 12 (men) 9. ALT >35 (men) or ALT >25 (women) 10. Alkaline Phosphatase >= 150 11. Bilirubin >2 g/dL 12. HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive 13. Pregnancy 14. Inability to provide informed consent
Affected Subjects
In order to be eligible to participate in this study, an affected participant must meet all of the following criteria:
1. >=2 years of age.
2. Meets one of the following:
a. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR
b. 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:
1. >= 18 years of age.
2. 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
A healthy volunteer who meets any of the following criteria will be excluded from participation in this study:
1. Any chronic medical condition, including (but not limited to) heart, kidney, or lung diseases
2. Taking any regular medications or supplements (with the exception of regular multivitamins and/or oral contraceptives)
3. Average alcohol consumption > 1 drink/day in past 6 months, per self-report
4. History of liver disease (with the exception of neonatal jaundice)
5. History of severe illness, infection or major surgery in the past year
6. History of cancer (with the exception of basal cell carcinoma resected > 1 year prior to enrollment)
7. BMI < 18 or BMI >25
8. Hemoglobin < 11 (women) or hemoglobin < 12 (men)
9. ALT >35 (men) or ALT >25 (women)
10. Alkaline Phosphatase >= 150
11. Bilirubin >2 g/dL
12. HIV positive, Anti-HCV positive, HBsAg positive or Anti-HBc positive
13. Pregnancy
14. Inability to provide informed consent
Principal Investigator
Referral Contact
For more information: