People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents

Running, not enrolling · Phase 4

Conditions studied: Diabetes Mellitus, Hepatitis C, Chronic, Cardiovascular Diseases

In brief

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....

Key facts

Study ID

NCT03520660

Run by

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

People needed

121

Starts

2018-10-19

Expected to finish

2032-12-31

Last updated by the study team

2026-08-07

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Phase I Treatment
• Pregnancy or lactation
• Inability to practice one form of adequate contraction for females of childbearing potential
• Prior treatment with a NS5a agent
• Current or prior history of any of the following:
• Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded
• Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
• Decompensated liver disease as defined by serum bilirubin >= 2.5 mg/dL (with direct bilirubin >= 1.5 mg/dL), INR >1.5 a serum albumin of less than 3 g/dL, or a history of ascites, hepatorenal syndrome, variceal bleeding, or hepatic encephalopathy
• Solid organ transplantation
• Significant pulmonary disease, significant cardiac disease
• History of malignancy or treatment for a malignancy within the past 3 years that is associated with a life expectancy <5 years (except adequately treated carcinoma in situ or basal cell carcinoma of the skin).
• Chronic liver disease of a non-HCV etiology with the exception of steatosis (e.g., chronic hepatitis B, hemochromatosis, Wilson s disease, alfa-1 antitrypsin deficiency, cholangitis).
• Evidence of harmful or hazardous drinking as defined as a score >= 8 on the AUDIT questionnaire.
• Co-infection with HIV defined as the presence of anti-HIV in serum.
• Clinically relevant drug abuse based on patient history within 12 months of screening.
• Use of medications contraindicated with use of sofosbuvir/velpatasvir within 21 days of the Baseline/Day 1 visit; this washout period does not apply to proton pump inhibitors, which can be taken up to 7 days before baseline Day 1 for the following:
• Acid reducing Agents
• Antiarrhythmics
• Anticancer
• Antimycobacterial
• HIV antivirals
• Herbal supplements
• HMG-CoA Reductase Inhibitors
• Use of antiviral medications within the last 30 days.

Where it is running

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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