Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT03520660
Eligibility Criteria:
* INCLUSION CRITERIA:
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.
* HCV RNA positive at screening.
* Subjects must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator.
Phase II Follow-up
* Male or female \>= 18 years of age.
* SVR24 following therapy with a direct acting antiviral agent regimen and available liver biopsy performed prior to treatment.
* Subject must be of generally good health as determined by the Investigator.
EXCLUSION CRITERIA:
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.
* Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent \>= 10 mg/day).
* Known hypersensitivity to sofosbuvir and velpatasvir, or formulation excipients.
* Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL
* Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study.
* Presence of conditions that, in the opinion of the investigators, would not allow the subject to n the current study for at least 1 year.
Phase II Follow-up
* Pregnancy
* Current or prior history of any of the following:
* Clinically significant illness (other than resolved 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
--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 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
* Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent \>= 10 mg/day)
* Hepatocellular carcinoma, or the presence of a mass on imaging studies of the liver that is suggestive of hepatocellular carcinoma, or an alpha-fetoprotein level of greater than 500 mg/mL
* Active psychiatric problems such as major depression, schizophrenia, bipolar illness, obsessive-compulsive disorder, severe anxiety, or personality disorder that, in the investigator s opinion, might interfere with participation in the study
* Presence of conditions that, in the opinion of the investigators, would not allow the patient to be followed in the current study for at least 1 year.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT03520660
Study Brief:
Protocol Section:
NCT03520660