Add-on Peginterferon Following Nucleos(t)Ide Analogue Treatment
Status:
Completed
Trial end date:
2018-05-21
Target enrollment:
Participant gender:
Summary
Background:
- Chronic hepatitis B is caused by a virus that infects the liver. Cure is not possible but
the virus can be controlled with the use of antiviral medicines,. Researchers think that
adding a second antiviral medicine might help.
Objective:
- To understand how peginterferon might help treat people with chronic hepatitis B. Also, to
see if peginterferon is safe to use with other antiviral medications.
Eligibility:
- Adults age 18 and older who have chronic hepatitis B and had therapy with 1 or more oral
medicines for hepatitis B for at least 4 years.
Design:
- Participants will be screened with physical exam and medical history. They will complete
health questionnaires about their levels of fatigue and pain. They will have blood and
urine tests. They may have an eye exam.
- Participants also will have a Fibroscan. A test to measure how stiff your liver is.
- Eligible participants will have a liver biopsy. Blood will be drawn.
- Participants will be admitted to the NIH Clinical Center. They will be injected with the
study drug. Then they will have a second liver biopsy. They will be discharged 24 hours
later.
- Participants will give themselves study drug injections under the skin weekly for 24
weeks.
- Participants will have 5 clinic visits during the 24-week treatment period. Then they
will have follow-up visits every 12 weeks for 48 weeks.
- During visits, participants may have a physical exam and medical history. They may have
blood and urine tests. They may have a Fibroscan and complete questionnaires. At the
final visit, they will also have a Fibroscan.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)