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 @ 3:57 AM
Ignite Modification Date:
2025-12-25 @ 3:57 AM
NCT ID:
NCT01841502
Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 and not older than 65 years at screening.
* Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
* Subject has a chronic HCV infection with genotype 1.
* Subject is eligible for telaprevir containing HCV treatment.
* Subject is on a stable dose of 20 mg paroxetine once daily for at least 4 weeks.
Exclusion Criteria:
* Documented history of sensitivity/idiosyncrasy to medicinal products or excipients.
* Pregnant female (as confirmed by a human chorionic gonadotropin (HCG) test performed less than 6 weeks before Day -1) or breast-feeding female. Female subjects of childbearing potential without adequate contraception, e.g. hysterectomy, bilateral tubal ligation, (non-hormonal) intrauterine device, total abstinence, double barrier methods, or two years post-menopausal. They must agree to take precautions in order to prevent a pregnancy throughout.
* Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
* Inability to understand the nature and extent of the trial and the procedures required.
* Participation in a drug trial within 60 days prior to the first dose of telaprevir.
* Use of relevant concomitant medication, as assessed by a hospital pharmacist (member of the study team).
* Hemoglobin \< 12 g/dL (females) or \< 13 g/dL (males) (7.4 respectively 8.0 mM).
* Poor- or ultrarapid metabolizer CYP2D6 (based on genetic testing)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01841502
Study Brief:
Protocol Section:
NCT01841502