Background:
- Chronic hepatitis D is a severe disease of the liver caused by infection with the
hepatitis D virus. The hepatitis D virus can only infect a person who also has hepatitis
B; therefore, people with delta hepatitis have both hepatitis B and hepatitis D virus
infection. Most people with hepatitis D eventually develop cirrhosis, which causes
scarring and damage to the liver. There is currently no effective treatment for chronic
hepatitis D.
- Lonafarnib is a drug that was originally designed to treat different types of cancer. It
may be able to prevent the hepatitis D virus from reproducing itself. However, it has
not been tested on people with hepatitis D. Researchers want to study different doses of
lonafarnib to see how they affect virus levels and other symptoms of hepatitis D.
Objectives:
- To test the safety and effectiveness of lonafarnib as a treatment for chronic hepatitis D.
Eligibility:
- Individuals at least 18 years of age who have chronic hepatitis D.
Design:
- Participants will be screened with a medical history and physical exam. They will have
blood and urine tests, eye exams, and imaging studies of the liver and gall bladder. A
liver biopsy may also be performed.
- Participants will receive either lonafarnib or placebo twice a day for 28 days. For the
first 3 days, participants will stay in the hospital to have frequent blood tests.
Participants will have four more clinic visits (on days 7, 14, 21, and 28) for blood and
urine tests. Eye exams and heart function tests will also be given. Men may be asked to
provide sperm samples for further testing.
- After the 28 days of treatment, participants will stop taking the drug or placebo. They
will have regular followup visits for up to 6 months after stopping treatment....
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)