NCT00001971 Evaluation of Patients With Liver Disease
| NCT ID | NCT00001971 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Condition | Hepatitis D |
| Study Type | OBSERVATIONAL |
| Enrollment | 8,050 participants |
| Start Date | 1992-05-27 |
| Primary Completion | — |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 8,050 participants in total. It began in 1992-05-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
* 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: 1. Suspected or evidence of acute or chronic liver disease on evaluation by a referring licensed independent practitioner (LIP), OR 2. 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
Contact & Investigator
T. Jake Liang, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Frequently Asked Questions
Who can join the NCT00001971 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 100 Years, studying Hepatitis D. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00001971 currently recruiting?
Yes, NCT00001971 is actively recruiting participants. Contact the research team at patricia.alcivar@nih.gov for enrollment information.
Where is the NCT00001971 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT00001971 clinical trial?
NCT00001971 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The principal investigator is T. Jake Liang, M.D. at National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The trial plans to enroll 8,050 participants.