People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Status:
Recruiting
Trial end date:
2032-12-31
Target enrollment:
Participant gender:
Summary
Background:
Chronic hepatitis C infects the liver. It may scar the liver. This is called cirrhosis and
may lead to liver cancer or death. Current chronic hepatitis C treatments cure most people.
But some keep getting complications even after it is cured. Researchers want to study why.
Objective:
To study the course and complications of liver disease after cure of hepatitis C infection.
Eligibility:
Adults 18 years and older infected with chronic hepatitis C virus who were never treated or
were treated and not cured and those who were cured
Design:
Participants will be screened with:
Blood and urine tests
Questionnaires
Liver ultrasound
Fibroscan. A probe vibrates the liver, testing stiffness.
In Phase 1, people with chronic hepatitis C will:
Have a 3-day hospital admission to repeat some screening tests and have a liver biopsy. A
small piece of liver is removed by needle passed through the skin.
Take 1 tablet containing 2 hepatitis C drugs once a day for 12 weeks.
Repeat some blood tests at 3 visits in those 12 weeks while on treatment, then 4 additional
visits in the next 24 weeks with more blood work collected.
Phase 1 participants who test negative for hepatitis C and all other eligible participants
will enter Phase 2.
Phase 2 participants will have a visit every 24 weeks for 10 years. These may include:
Repeats of screening tests
Questionnaires
Scans
Stool tests
Chest x-ray
Heart function test
Endoscopy. A tube guides a camera into the upper digestive system.
At about 5 years, participants will have another liver biopsy.
Some participants will give separate consent for genetic testing and a special blood
procedure.
Phase:
Phase 4
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)