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 @ 11:51 PM
Ignite Modification Date:
2025-12-24 @ 11:51 PM
NCT ID:
NCT02600351
Eligibility Criteria:
Key Inclusion Criteria:
* HCV RNA \> 15 IU/mL at screening
* HCV genotype 1 or 4
* Chronic HCV infection (≥ 6 months)
* Prior virologic failure after treatment with SOF in combination with simeprevir (SMV) ± RBV or with RBV ± pegylated interferon (PEG)
* Cirrhotic and non-cirrhotic as determined by standard methods
* Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
Key Exclusion Criteria:
* Prior exposure to approved or experimental non-structural protein (NS5A) inhibitors
* Prior exposure to nucleos(t)ide polymerase inhibitors, other than SOF
* Pregnant or nursing female or male with pregnant female partner
* Coinfection with HIV or hepatitis B virus
* Current or prior history of clinical hepatic decompensation
* Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
* Chronic use of systemic immunosuppressive agents
* History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02600351
Study Brief:
Protocol Section:
NCT02600351