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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT02350569
Eligibility Criteria:
Key Inclusion Criteria:
* Willing and able to provide written informed consent or for those individuals where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative (LAR) willing and able to provide consent on behalf of the individual.
* HCV RNA infection with quantifiable virus at screening
* Must have chronic genotype 1 or 4 HCV infection for ≥ 6 months by medical history or liver biopsy
* Currently on the liver transplantation wait list
* Screening electrocardiogram (ECG) without clinically significant abnormalities.
* A negative serum pregnancy test result is required for females
Key Exclusion Criteria:
* Any previous solid organ transplant
* Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with participant's treatment, assessment, or compliance
* HIV infection or a positive hepatitis B virus surface antigen result
* History of malignancy (with exception of hepatocellular carcinoma within Milan criteria, certain resolved skin cancers or other early cancer for which surgical resection is considered to be completely curative)
* Treatment with any approved or experimental medication with known anti-HCV activity within 1 month prior to screening date
* Prior exposure to an HCV non-structural protein (NS)5A inhibitor
* Patients on hemodialysis prior to or at the time of transplantation will be excluded
* Creatinine clearance (CLcr) \< 40 mL/min at screening or \< 40 mL/min on day of transplant
* Participation in a clinical study with an investigational drug or biologic within 28 days prior to screening visit
* Receipt or planned receipt of an organ from an HCV positive donor
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02350569
Study Brief:
Protocol Section:
NCT02350569