New Treatment Response in People With and Without Cirrhosis From Chronic Hepatitis C
Status:
Completed
Trial end date:
2015-11-01
Target enrollment:
Participant gender:
Summary
Background:
- Some people who have chronic hepatitis C do not respond to the usual treatment with
peginterferon and ribavirin. New chronic hepatitis treatments are being developed that may
work better for different people. The treatments will look at how specific genes interact
with the drugs. Researchers want to see how well these new drugs work in people whose chronic
hepatitis C has not responded or only partly responded to the usual treatment drugs.
Objectives:
- To compare new treatments for people with chronic hepatitis C.
Eligibility:
- Individuals at least 18 years of age who have chronic hepatitis C that has not responded to
standard treatments.
Design:
- Participants will be screened with a physical exam and medical history. Blood and urine
samples will be collected. Liver scans and a biopsy will be taken before the start of
treatment.
- Participants will be separated into two groups. One group will have the new treatment
drugs (assunaprevir and daclatasvir). The second group will have these two drugs as well
as peginterferon and ribavirin. All participants will have an initial 4-day hospital
stay with regular blood tests to see how the start of the treatment works.
- The first group will take the new study drug tablets daily for 24 weeks. Those who do
not respond to this treatment will also start to take peginterferon and ribavirin, and
the treatment will continue for 24 weeks after starting the additional drugs.
- The second group will take all four drugs according to the standard dosing schedule for
24 weeks.
- Treatment will be monitored with frequent blood tests. Liver scans, biopsies, and other
tests will be performed as directed by the study doctors.
- Participants will have 24 weeks of regular followup visits.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)