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:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01858012
Eligibility Criteria:
Inclusion criteria for HCV participants:
* Male or female patients between 18 and 60 years of age
* Body mass index (BMI) \> 20 Kg/m2
* Serologic evidence of hepatitis C infection by anti-HCV antibody
* Detectable plasma HCV-RNA
* Compensated liver disease with the following minimum biochemical parameters: prothrombin time \< 2 seconds prolonged compared to control and bilirubin \< 3 mg/dL
* Willingness to provide informed consent
Inclusion criteria for healthy Latino volunteers (without HCV infection):
-Same inclusion criteria as above except no evidence of HCV infection (anti-HCV antibody negative)
Inclusion criteria for participation in 6-week alcohol abstinence follow-up testing:
-Latinos who are moderate1 alcohol drinkers (1NIAAA definition: female: no more than 3 drinks on any day \& no more than 7 drinks per week; male: no more than 4 drinks on any day and no more than 14 drinks per week).
Steady-State Plasma Glucose \< 180 mg/dL
Exclusion criteria:
* Hepatitis B or HIV infection
* Subjects with liver disease other than that caused by HCV
* Known history of diabetes, or fasting plasma glucose concentration \>126 mg/dl
* Known history of cirrhosis of the liver, as well as individuals with decompensated liver disease such as those with ascites, variceal bleeding, and encephalopathy
* Known history of pancreatitis
* Prior or current treatment for HCV
* Heavy alcohol use (\>80 g/d)
* Subjects of lipid lowering agents, steroid/ anabolic therapy
* Significant medical illness that would interfere with the completion of the study
Exclusion criteria for healthy (non HCV) Latino volunteers:
-Same as above, including subjects with HCV infection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01858012
Study Brief:
Protocol Section:
NCT01858012