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

NCT03520660 | Active Not Recruiting Phase 4 FDA Drug

• 2 other identifiers: 18009118-DK-0091
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus; Hepatitis C, Chronic; Cardiovascular Diseases

Keywords

Natural History; Hepatitis C Virus; Hepatocellular Carcinoma; Fibrosis; Immune Response

Outcome Measures

Primary Outcomes (2)

• Phase II: Liver-related clinical outcome, HCC, or liver-related mortality

  Composite of ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, variceal hemorrhage, hepatocellular carcinoma, liver-related mortality

  480 Weeks

• Phase I - SVR 12

  SVR at 12 weeks after completion of 12 weeks of treatment

  24 weeks

Secondary Outcomes (5)

• Phase II: All-cause mortality

  480 weeks

• Phase II: Change in Fibroscan

  480 weeks

• Phase II: Assess Regression in Portal Hypertension

  480 weeks

• Phase II: HCC

  480 weeks

• Phase II: Change in Ishak fibrosis score

  480 weeks

Study Arms (3)

Phase I

EXPERIMENTAL

Phase I treatment

Drug: Epclusa

Phase II after Phase I

NO INTERVENTION

Participants who achieved SVR12 in Phase I

Phase II without Phase I

NO INTERVENTION

Participants who achieved SVR 24 previously

Interventions

Epclusa DRUG

sofosbuvir/velapatasvir combination (Epclusa)

Phase I

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Phase I Treatment
• Male or female \>= 18 years of age
• Either treatment naive or experienced defined as failure of a prior course of interferon-based and ribavirin, DAA plus interferon and DAA only
• Confirmation of chronic HCV infection documented by:
• A positive HCV RNA or positive HCV genotyping test at least 6-months prior to the Baseline/Day 1 visit
• A liver biopsy performed prior to screening visit showing evidence of chronic hepatitis.
• Subjects must have the following laboratory parameters at screening:
• ALT \<= 10 x the upper limit of normal (ULN)
• AST \<= 10 x ULN
• Total bilirubin \<2.5 mg/dL, Direct bilirubin \<= 1.5 ULN
• Platelets \>= 50,000 K/mm\^3
• HbA1c \<= 8.5%
• Hemoglobin \>= 10g/dL
• Albumin \>= 3g/dL
• INR \<= 1.5 unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.

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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Diabetes Mellitus; Hepatitis C, Chronic; Cardiovascular Diseases; Hepatitis C; Carcinoma, Hepatocellular; Fibrosis

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Marc G Ghany, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 11, 2018
• Study Start: October 19, 2018
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 7, 2026

Record last verified: 2026-01-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)