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:
2025-12-26 @ 4:01 PM
Ignite Modification Date:
2025-12-26 @ 4:01 PM
NCT ID:
NCT03022006
Eligibility Criteria:
Inclusion criteria
* Patients aged 20 years or older at the time of consent
* Patients who received an adequate explanation prior to the study and provided written consent for participation in the study
* Hemodialysis patients complicated by chronic hepatitis C who have HCV Genotype 1b infection and do not meet the exclusion criteria listed in the following section
Exclusion criteria
* Patients with a past history of hypersensitivity to HCV protease inhibitors and NS5A inhibitors
* Patients with serious liver dysfunction (Child-Pugh Class B or C)
* Patients with difficult-to-control heart disease (e.g., myocardial infarction, heart failure, and arrhythmia)
* Patients who have malignant tumors, including hepatoma, at the start of treatment
* Patients on treatment with drugs listed in the contraindications for coadministration in the package insert (e.g., some antifungals, some antiepileptics, and human immunodeficiency virus (HIV) protease inhibitors)
* Patients with albumin \<3.0 g/dL and platelets \<75,000 /μL
* Other patients judged to be inappropriate to participate in the study by the primary physician
* Other patients judged to be inappropriate as study subjects by the study manager
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT03022006
Study Brief:
Protocol Section:
NCT03022006