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 @ 4:58 AM
Ignite Modification Date:
2025-12-25 @ 4:58 AM
NCT ID:
NCT01779518
Eligibility Criteria:
Inclusion Criteria:
* Age \> or = 18 years
* Previously undergone orthotopic liver transplant (OLT) at least 2 months prior to the planned start of dosing
* Aggressive Hepatitis C infection (including fibrosing cholestatic hepatitis C)
* Life expectancy of \< 12 months if the HCV is left untreated
Exclusion Criteria:
* History of clinically significant drug allergy to nucleoside/nucleotide analogs
* Participation in a clinical study with an investigational drug or biologic within 1 month prior to anticipated dose administration, unless information is available to determine that there is no safety or drug-drug interaction risk to the subject
* Unable or unwilling to follow the contraception requirements
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01779518
Study Brief:
Protocol Section:
NCT01779518