Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon
Status:
Completed
Trial end date:
2020-11-09
Target enrollment:
Participant gender:
Summary
Background:
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
liver.
Objectives:
To see if combining lonafarnib, ritonavir, and lambda interferon is safe and effective to
treat chronic hepatitis D infection.
Eligibility:
Adults at least 18 years old with chronic hepatitis D infection
Design:
Participants will be screened with a physical exam, medical history, and blood and urine
tests.
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
sedated.
- 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
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)