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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT04309734
Eligibility Criteria:
Inclusion Criteria:
All:
* Body mass index (BMI) of 18-35 kg/m2
* Must agree to use protocol-specified methods of contraception
* Negative pregnancy test
* Willing to comply with the study requirements and to provide written informed consent
Additional for Part A:
-18-55 years of age
Additional for Part B:
* 18-65 years of age
* HCV genotype 1, 2 or 3
* Documented history compatible with chronic hepatitis C
* HCV RNA ≥ 10,000 IU/mL at Screening
Exclusion Criteria:
All:
* Pregnant or breastfeeding
* Abuse of alcohol or drugs
* Use of other investigational drugs within 30 days of dosing
* Other clinically significant medical conditions
Additional for Part B:
* Prior exposure to any HCV NS5A inhibitor
* Cirrhosis
* Co-infection with hepatitis B virus or HIV
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04309734
Study Brief:
Protocol Section:
NCT04309734