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 @ 12:06 AM
Ignite Modification Date:
2025-12-25 @ 12:06 AM
NCT ID:
NCT02760758
Eligibility Criteria:
Main Inclusion Criteria:
HV and HCV INFECTED SUBJECTS:
* Male or female aged ≥ 18 to ≤ 65 years;
* Body mass index ≥ 18.5 to ≤ 35.0 kg/m2;
* Body weight ≥ 50 kg;
* Negative screening for alcohol and drugs of abuse;
* Normal results on 12-lead electrocardiogram (ECG);
* For females, negative result on a pregnancy test.
HCV INFECTED SUBJECTS:
* HCV treatment-naïve subjects must have not received prior direct acting agent (DAA) treatment for hepatitis C infection;
* Documented clinical history compatible with chronic hepatitis C;
* HCV Genotype 1 by HCV genotyping performed at Screening;
* Plasma HCV RNA ≥ 5.0 log10 IU/mL at Screening;
* Laboratory evidence of no cirrhosis (negative liver biopsy or fibroscan or FibroTest, F2 or lower) within one year prior to study), if these are not available, do a FibroTest at screening, which must be F2 or lower.
Main Exclusion Criteria:
HV and HCV INFECTED SUBJECTS:
* Females who are pregnant or are lactating;
* Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV);
* Abuse of alcohol and/or drugs that could interfere with adherence to study requirements as judged by the investigator;
* Positive screen result for drugs of abuse or alcohol on Day -1. Use of other investigational drugs within 60 days of dosing;
* Subject with intestinal malabsorption;
* Presence of out-of-range cardiac interval on the screening ECG or other clinically significant ECG abnormalities;
* Serum creatinine \> upper limit of normal (ULN);
* Any clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
HEALTHY VOLUNTEERS:
* Positive screen for anti-HCV antibody
HCV INFECTED SUBJECTS:
* Clinical (in the opinion of the investigator) or laboratory evidence of cirrhosis;
* History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency;
* History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC;
* Active clinically significant diseases.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02760758
Study Brief:
Protocol Section:
NCT02760758