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 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT01909804
Eligibility Criteria:
Inclusion Criteria:
* Body mass index (BMI) ≥ 18 kg/m\^2
* HCV RNA ≥ 10000 IU/mL at screening
* Prior treatment failure to a regimen including interferon with or without RBV
* HCV genotype 1 or 3
* Chronic HCV infection
* Cirrhosis determination
* Use of highly effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
* Current or prior history of clinically significant illness other than HCV
* Screening ECG with clinically significant abnormalities
* Prior exposure to HCV specific direct acting antiviral agent
* Pregnant or nursing female or male with pregnant female partner
* Chronic liver disease of non-HCV etiology
* Hepatitis B
* Active drug abuse
* Use of any prohibited concomitant medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01909804
Study Brief:
Protocol Section:
NCT01909804