Open studies conducted by NIDDK Principal Investigators appear below. Study statuses may include the following:
Open: Recruiting - Currently recruiting participants and open to everyone who meets eligibility criteria.
Open: Active, Not Recruiting - Participants are receiving an intervention or being examined, however new participants
are not being recruited or enrolled.
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.
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
Infection with hepatitis D virus leads to a chronic liver disease with no effective
treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication
still needs more research. Ritonavir makes other drugs more effective and is used with
lonafarnib to make it more effective. Lambda interferon stimulates the body s response to
viruses. Researchers want to see if combining these drugs fights hepatitis D and helps the
To see if combining lonafarnib, ritonavir, and lambda interferon is safe and effective to
treat chronic hepatitis D infection.
Adults at least 18 years old with chronic hepatitis D infection
Participants will be screened with a physical exam, medical history, and blood and urine
Throughout the study, all participants will:
- Follow rules for medicine, food, and contraception
- Take hepatitis B medicine
- Have weight checked
- Have routine blood and urine tests
- Give stool samples
- Female participants will have pregnancy tests.
Participants will have 3 visits before treatment. They will repeat screening tests and have a
heart test and liver scan.
Participants will have a 5-day inpatient stay. They will:
- Baseline blood and urine tests
- Have eye tests
- Answer health questions
- Have a liver sample taken and liver blood pressure measured. Participants will be
- Have reproductive tests
- Start the study drugs and have blood draws
Over 24 weeks of treatment, participants will:
-Take 2 study drugs by mouth every day and 1 as a weekly injection
The trial is Open with a status of Active, not recruiting.
Christopher Koh, M.D.
- 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.
- To learn more about how NCPH develops over time.
- 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.
- 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
- 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
- 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.
Anusha Vittal, M.D.
Catherine A Nadal, R.N.