Hepatitis DNCT00001971
Evaluation of Patients With Liver Disease
An observational study of Hepatitis D and Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis D, Hepatitis C, Hepatitis B
- How many people
- 8,050 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 1992to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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....
Read the detailed description
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.
- Conditions
- Hepatitis D, Hepatitis C, Hepatitis B, Liver Disease
- Keywords
- Hepatitis B, Hepatitis C, Hepatitis D, Chronic Hepatitis, Natural History, Liver Disease
- Medical subject headings
- Hepatitis D, Hepatitis C, Hepatitis B, Liver Diseases, Hepatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy individuals | Healthy individuals who have recovered from liver diseases or who are healthy volunteers | |
| Patients | Liver disease patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response
Measured: Annual visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2000 (estimated)
- Study start27 May 1992
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,050 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- T. Jake Liang, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001971
- Sponsor's protocol ID
- 910214
- Other IDs
- 91-DK-0214
- Status last verified
- 23 Sep 2026
- First submitted
- 12 Jul 2006
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali RO, Moon MS, Townsend EC, Hill K, Zhang GY, Bradshaw A, Guan H, Hamilton D, Kleiner DE, Auh S, Koh C, Heller T. Exploring the Link Between Platelet Numbers and Vascular Homeostasis Across Early and Late Stages of Fibrosis in Hepatitis C. Dig Dis Sci. 2020 Feb;65(2):524-533. doi: 10.1007/s10620-019-05760-x. Epub 2019 Aug 12.
PubMed 31407130Kefalakes H, Koh C, Sidney J, Amanakis G, Sette A, Heller T, Rehermann B. Hepatitis D Virus-Specific CD8+ T Cells Have a Memory-Like Phenotype Associated With Viral Immune Escape in Patients With Chronic Hepatitis D Virus Infection. Gastroenterology. 2019 May;156(6):1805-1819.e9. doi: 10.1053/j.gastro.2019.01.035. Epub 2019 Jan 18.
PubMed 30664876Koh C, Turner T, Zhao X, Minniti CP, Feld JJ, Simpson J, Demino M, Conrey AK, Jackson MJ, Seamon C, Kleiner DE, Kato GJ, Heller T. Liver stiffness increases acutely during sickle cell vaso-occlusive crisis. Am J Hematol. 2013 Nov;88(11):E250-4. doi: 10.1002/ajh.23532. Epub 2013 Aug 1.
PubMed 23828202
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Liver Disease
- ClinicalTrials.gov ID
- NCT00001971
- Acronym / sponsor ID
- 910214
- Conditions
- Hepatitis D, Hepatitis C, Hepatitis B, Liver Disease
- Keywords
- Hepatitis B, Hepatitis C, Hepatitis D, Chronic Hepatitis, Natural History, Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,050 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 27 May 1992 (actual)
- First posted
- 19 Jan 2000 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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....
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy individuals | – | –Healthy individuals who have recovered from liver diseases or who are healthy volunteers |
| Patients | – | –Liver disease patients |
Who may qualify
- Ages
- 2 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (10 listed)
- 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.
- Meets one of the following:
- Healthy Volunteers
Key exclusion criteria (19 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Derived from this study: PubMed 31407130Ali RO, Moon MS, Townsend EC, Hill K, Zhang GY, Bradshaw A, Guan H, Hamilton D, Kleiner DE, Auh S, Koh C, Heller T. Exploring the Link Between Platelet Numbers and Vascular Homeostasis Across Early and Late Stages of Fibrosis in Hepatitis C. Dig Dis Sci. 2020 Feb;65(2):524-533. doi: 10.1007/s10620-019-05760-x. Epub 2019 Aug 12.
- Derived from this study: PubMed 30664876Kefalakes H, Koh C, Sidney J, Amanakis G, Sette A, Heller T, Rehermann B. Hepatitis D Virus-Specific CD8+ T Cells Have a Memory-Like Phenotype Associated With Viral Immune Escape in Patients With Chronic Hepatitis D Virus Infection. Gastroenterology. 2019 May;156(6):1805-1819.e9. doi: 10.1053/j.gastro.2019.01.035. Epub 2019 Jan 18.
- Derived from this study: PubMed 23828202Koh C, Turner T, Zhao X, Minniti CP, Feld JJ, Simpson J, Demino M, Conrey AK, Jackson MJ, Seamon C, Kleiner DE, Kato GJ, Heller T. Liver stiffness increases acutely during sickle cell vaso-occlusive crisis. Am J Hematol. 2013 Nov;88(11):E250-4. doi: 10.1002/ajh.23532. Epub 2013 Aug 1.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
T. Jake Liang, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis D and Hepatitis C, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia E Alcivar ((301) 435-6121, patricia.alcivar@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predisposition and outcomes related to liver disease susceptibility, progression, and treatment response (time frame: Annual visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001971, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.