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 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02469012
Eligibility Criteria:
Inclusion Criteria:
* Patients with chronic hepatitis C and indication for interferon-free antiviral therapy.
* Written informed consent to study participation, especially to long-term follow-up monitoring of quality of life, emotional state, fatigue, and neurocognitive performance after antiviral treatment.
* Age of study participants: between 18 and 75 years.
* At study entry, all participating patients need to have documented antibodies to HCV and circulating HCV-RNA as measured by reverse-transcription polymerase chain reaction (Cobas Amplicor HCV MonitorTM test, Roche Diagnostics)
Exclusion Criteria:
* Insufficient knowledge of the German language or cognitive impairment (due\* to the indispensable application of questionnaires and the TAP, test battery of attentional performance).
* Age under 18 years or over 75 years
* Coinfections such as hepatitis B virus or human immunodeficiency virus
* Severe internal diseases (e.g., cancer, ischemic heart disease, autoimmune disease)
* Major depressive disorder (according to DSM-IV criteria), psychosis, active intravenous drug use or alcohol abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02469012
Study Brief:
Protocol Section:
NCT02469012