Peginterferon Lambda and Lonafarnib Boosted With Ritonavir 48-Week Combination Therapy for Delta Hepatitis
Status:
Withdrawn
Trial end date:
2024-05-22
Target enrollment:
Participant gender:
Summary
Background:
Chronic hepatitis D is a serious liver disease caused by a virus. Currently, no medications
are approved to treat chronic hepatitis D.
Objective:
To test a combination of 3 drugs in people with chronic hepatitis D.
Eligibility:
People 18 years or older with chronic hepatitis D.
Design:
Participants will be in the study about 2 years. They will have 3 inpatient stays of 3 to 5
days.
Participants will be screened. They will have a physical exam with blood tests. They will
have a test of their heart function and an ultrasound: a wand that uses sound waves to create
images of the liver will be rubbed over the skin on their torso.
Participants will stay in the clinic for a 3-day baseline visit. They will have imaging
scans, an eye exam, and a visit with a reproductive specialist. They will have a liver
biopsy: about 1 inch of liver tissue will be removed, either with a tube inserted through a
vein in the neck, or with a needle inserted through the participant s side.
Participants will take the study drugs for 48 weeks. Two of them are tablets taken twice a
day at home; 1 is a shot administered once a week. Participants will begin taking the drugs
during a 5-day stay in the clinic. Then they will have 15 outpatient visits while taking the
drugs and 7 more after they finish.
The last 3-day clinic stay will be 6 months after participants finish taking the drugs. The
liver biopsy, imaging scans, and other tests will be repeated.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)