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:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-24 @ 3:37 PM
NCT ID:
NCT01899092
Eligibility Criteria:
Inclusion Criteria:
Subjects must a history of chronic HCV infection defined as documented HCV genotype 1 infection for at least 6 months.
* Subjects must have:
1. Documented failure to respond to prior treatment or relapse with a combination of peg-interferon (peg-IFN), ribavirin (RBV), and either boceprevir or telaprevir, OR a combination of peg-IFN and ribavirin or
2. Subject is ineligible or unwilling to receive a combination of peg-IFN, RBV, and either boceprevir or telaprevir.
* Female subjects have to be of non-childbearing potential, defined as meeting any of the following criteria:
1. Female subjects over the age 60.
2. Female subjects aged 45-60 years old must be amenorrhoeic for at least 2 years and must have serum follicle stimulating hormone (FSH) levels \> 30 IU/L.
3. Female subjects with hysterectomy or bilateral oophorectomy. All female subjects must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline.
* Male subjects and their partners must be willing to comply with the following requirements to use 2 methods of effective contraception: Male subjects with a vasectomy must use a condom. Without a vasectomy, male subjects must use a condom. The female must be sterile or willing to use an additional form of contraception.
* Baseline HCV RNA level of \> 100,000 IU/mL and:
* No evidence of cirrhosis at Screening
* At least 3 months since prior therapy for HCV
* A willingness to enroll in a 5 year follow-up safety study
Exclusion Criteria:
* Body mass index \< 18.5 or \> 30
* Total body weight \> 80 KG
* Female subjects of childbearing potential (including females with tubal ligation) or women who are pregnant or nursing
* Male subjects who are unwilling to provide the required semen samples
* Presence of nAb levels to AAV8 that abrogate AAV8 transduction
* Severe Liver disease
* Hepatocellular carcinoma (HCC) or suspicion of HCC
* Coronary artery disease
* Platelet count of \< 150 x 109/L or Creatinine ≥ 1.5 mg/dL at Screening
* Hypertension with systolic blood pressure consistently ≥ 130 mmHg or diastolic blood pressure consistently ≥ 90 mmHg
* Screening examinations indicative of possible occult malignancy unless cancer has been excluded
* Family history of colon cancer in any first-degree relative unless ruled out by colonoscopy
* Positive for human immunodeficiency virus 1 (HIV1) or HIV2 antibody
* Co-infection with hepatitis B virus
* History of autoimmune disease
* Renal impairment
* Hospitalization for liver disease within 60 days of Screening
* Use of drugs of abuse in the prior 3 months
* Other concomitant disease or condition likely to significantly decrease life expectancy or cancer
* Treatment with an investigational drug within 6 months preceding the first dose of trial medication
* Received an AAV vector previously or any other gene transfer agent in the previous 6 months
* History of cardiac abnormalities, as assessed at the Screening Visit
* Twelve-lead ECG demonstrating QTcB \> 465 ms at Screening
* Chronic hepatic diseases
* Evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, psychiatric, neurologic, or allergic diseases.
* Evidence of autoimmune disease or pre-existing autoimmune or antibody-mediated diseases
* Use of immunosuppressive medications within 6 months before the entry into this study, except for inhaled or topical corticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01899092
Study Brief:
Protocol Section:
NCT01899092