People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
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|ClinicalTrials.gov Identifier: NCT03520660|
Recruitment Status : Recruiting
First Posted : May 10, 2018
Last Update Posted : October 24, 2018
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.
To study the course and complications of liver disease after cure of hepatitis C infection.
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
Participants will be screened with:
Blood and urine tests
Fibroscan. A probe vibrates the liver, testing stiffness.
In Phase 1, people with chronic hepatitis C will:
Have a 3-day clinic stay 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 screening tests at 3 visits in those 12 weeks, then 4 visits in the next 24 weeks.
Phase 1 participants who test negative for hepatitis C and all other 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
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.
|Condition or disease|
|Diabetes Mellitus Hepatitis C, Chronic Cardiovascular Diseases|
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||Long-Term Follow-Up Of Subjects With CHC Who Achieved A Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents|
|Actual Study Start Date :||October 19, 2018|
|Estimated Primary Completion Date :||December 31, 2032|
|Estimated Study Completion Date :||December 31, 2032|
patients with chronic HCV infection
- Liver-related outcomes [ Time Frame: 5 and 10 years ]
- Non-liver related outcomes [ Time Frame: 5-10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520660
|Contact: Marc G Ghany, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Marc G Ghany, M.D.||National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)|