Clinical Trials
Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:
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Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
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Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants
are not being recruited or enrolled.
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Open: Enrolling by Invitation - People in a particular population were selected in advance and invited to participate.
The study is not open to everyone who meets the eligibility criteria.
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Open: Available for Expanded Access - Patients who are not participants in the clinical study may be able to
gain access to the drug, biologic, or medical device being studied.
Studies Seeking Patients
Background:
Primary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of
the
liver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease.
Researchers want to learn more about this disease.
Objective:
To understand the biological causes of primary sclerosing cholangitis.
Eligibility:
Adults age 18 and older who have primary sclerosing cholangitis.
Design:
Participants will be screened with a medical history, physical exam, and blood tests.
Participants will give blood, saliva, urine, and stool samples. They will have nasal swabs.
They will complete surveys.
Participants will get an intravenous (IV) catheter. A plastic tube is inserted into an arm
vein.
Participants will have a colonoscopy. A tube with a video camera at the end is inserted into
the rectum.
Participants will have an upper endoscopy. A scope with a light and camera at its tip is used
to look inside the upper digestive tract.
Participants will have a liver biopsy, entering through the chest wall or a neck vein. Blood
is drawn from a blood vessel that carries blood to the liver. A liver tissue sample is taken.
Participants will have magnetic resonance imaging or spectroscopy. They will get a contrast
agent through an IV.
Participants may have an optional bone marrow aspiration. A large needle is inserted into the
hip to withdraw marrow.
Participants will have a liver ultrasound.
Participants will complete a 3-day food diary. They will have a nutrition assessment.
Participants may give contact details for people who live with them, to also take part in
this study.
Participation will last for 12 months....
The trial is Open with a status of Recruiting.
Investigator:
Theo Heller, M.D.
Referral Contacts:
Alaina Magnani
(301) 451-6984
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Background:
In non-alcoholic fatty liver disease (NAFLD), fat accumulates in the liver and can cause
damage. Researchers want to learn what causes the damage NAFLD, and to see if a medication
can help.
Objective:
To find out how the liver in people with NAFLD responds to feeding, and how this relates to
their response to the drug semaglutide.
Eligibility:
People with NAFLD and healthy volunteers ages 18 and older
Design:
Participants will be screened with:
Medical history
Physical exam
Blood tests
Imaging: A machine will take pictures of the participant s body.
Within 2-8 weeks of enrollment, participants will stay in the clinic for several days. This
includes:
Blood, urine, heart, and imaging tests
For NAFLD participants only: A needle-like device will remove a small biopsy of the liver and
fatty tissue.
Participants will be alone in a special room for 5 hours. They will breathe through a tube
under the nostrils. They will have blood drawn several times.
The baseline visit concludes participation for healthy volunteers but NAFLD participants will
contine.
About 6 weeks after discharge, participants will stay in the clinic again and repeat the
tests. They will get their first semaglutide dose by injection.
Participants will have visits weeks 1, 2, 4, 8, 12, 16, 20, and 24 of treatment. Visits
include blood tests.
Participants will inject semaglutide once a week at home.
At week 30, participants will stay in the clinic again and repeat the tests.
Participants will have a final visit 12 weeks after stopping treatment. This includes blood
and urine tests.
...
The trial is Open with a status of Recruiting.
Investigator:
Yaron Rotman, M.D.
Referral Contacts:
Yaron Rotman, M.D.
(301) 451-6553
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Background:
Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and
may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people.
But some keep getting complications even after it is cured. Researchers want to study why.
Objective:
To study the course and complications of liver disease after cure of hepatitis C infection.
Eligibility:
Adults 18 years and older infected with chronic hepatitis C virus who were never treated or
were treated and not cured and those who were cured
Design:
Participants will be screened with:
Blood and urine tests
Questionnaires
Liver ultrasound
Fibroscan. A probe vibrates the liver, testing stiffness.
In Phase 1, people with chronic hepatitis C will:
Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A
small piece of liver is removed by needle passed through the skin.
Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks.
Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional
visits in the next 24 weeks with more blood work collected.
Phase 1 participants who test negative for hepatitis C and all other eligible participants
will enter Phase 2.
Phase 2 participants will have a visit every 24 weeks for 10 years. These may include:
Repeats of screening tests
Questionnaires
Scans
Stool tests
Chest x-ray
Heart function test
Endoscopy. A tube guides a camera into the upper digestive system.
At about 5 years, participants will have another liver biopsy.
Some participants will give separate consent for genetic testing and a special blood
procedure.
The trial is Open with a status of Active, not recruiting.
Investigator:
Marc G Ghany, M.D.
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Background:
- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure
in the blood vessels of the liver. It seems to start slowly and not have many warning signs.
Many people may not even know that they have a liver disease. There are no specific
treatments for NCPH.
Objectives:
- To learn more about how NCPH develops over time.
Eligibility:
- People age 12 and older who have NCPH or are at risk for getting it. In the past year, they
cannot have had other types of liver disease that typically result in cirrhosis, liver
cancer, or active substance abuse.
Design:
- Participants will have 2 screening visits.
- Visit 1: to see if they have or may develop NCPH.
- Medical history
- Physical exam
- Urine and stool studies
- Abdominal ultrasound
- Fibroscan. Sound waves measure liver stiffness.
<TAB>- Visit 2:
- Blood tests
- Abdominal MRI
- Echocardiogram
- Questionnaire
- Liver blood vessel pressure (hepatic venous portal gradient (HVPG)) measurement. This is
done with a small tube inserted in a neck vein.
- They may have a liver biopsy.
- All participants will visit the clinic every 6 months for a history, physical exam, and
blood tests. They will also repeat some of the screening tests yearly.
- Participants with NCPH will also have:
- Upper endoscopy test. A tube inserted in the mouth goes through the esophagus and
stomach.
- At least every 2 years: Esophagogastroduodenoscopy.
- At least every 4 years: testing including HVPG measurements and liver biopsy.
- Participants without NCPH will also have:
- Liver biopsy and HVPG measurements to see if they have NCPH.
- Every 2 years: abdominal MRI and stool studies.
- The study will last indefinitely.
The trial is Open with a status of Recruiting.
Investigator:
Theo Heller, M.D.
Referral Contacts:
Shani C Scott, R.N.
(301) 435-6121
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The purpose of this study is to establish retrospectively a nationwide registry of patients
who have suffered drug-induced liver injury (DILI), and to collect, immortalize, and store
serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for
subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The
primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of
individuals who have experienced severe DILI and the relevant clinical data concerning the
episode of DILI; and, (b) to create a bank of biological specimens obtained from these
individuals. These biological specimens will be DNA, plasma, and immortalized lymphocytes.
Immortalized lymphocytes will provide unlimited amounts of genomic DNA for study as well as
living immune cells for phenotyping studies.
A secondary goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD
database so that they may be recontacted in the future. It is expected that this will
facilitate additional studies exploring the mechanisms of DILI.
The trial is Open with a status of Recruiting.
Investigator:
Huiman X. Barnhart, PhD
Referral Contacts:
Eilene Pham
919-660-7253
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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.
The trial is Open with a status of Recruiting.
Investigator:
T. Jake Liang, M.D.
Referral Contacts:
Patricia E Alcivar
(301) 435-6121
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Last Reviewed October 2023
