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 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT03570112
Eligibility Criteria:
Inclusion Criteria:
* Age 18 or older
* Chronic HCV infection, as defined by positive HCV antibody with confirmation of positive HCV RNA PCR at least 6 months apart, per 2017 AASLD/IDSA criteria. Infection with any genotype (including mixed genotypes) is permitted.
* If the diagnosis of chronic HCV is not established by two positive viral load (RNA PCR) tests 6 months apart, subjects may be enrolled and followed until the 6-month test is performed. If the follow-up viral load test is negative (i.e. the woman had acute infection that has cleared), the participant will be excluded from further study participation. All participants excluded for this reason will be replaced.
* Singleton pregnancy, up to and including 36 weeks' gestation, as documented by fetal ultrasound at any time during the pregnancy.
* Willing and able to understand and sign the informed consent form
* Willing and able to sign release of Information forms for their own medical and obstetric care and for their infant's neonatal and pediatric care for one year following delivery, or when the last study viral load test is performed, whichever comes later.
Exclusion Criteria:
* Co-infection with chronic hepatitis B.
* Active injection drug use, defined as the parenteral use of any substance for non-medicinal purposes in the previous 60 days. Potential subjects who have a history of active injection drug use will be referred to both syringe services programs to prevent the acquisition of HIV and HBV and to substance abuse treatment. Potential subjects who have injected within the last 60 days may be re-screened if they participate in a drug treatment program, subject to the discretion of the investigator.
* Decompensated cirrhosis, as determined by clinical history or examination
* Any major medical comorbidity that may confound assessment, such as cardiomyopathy, pulmonary hypertension, type 1 diabetes mellitus or similar serious medical conditions at the discretion of the investigator. Gestational diabetes mellitus or co-infection with HIV are not criteria for exclusion.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03570112
Study Brief:
Protocol Section:
NCT03570112