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 @ 4:19 PM
Ignite Modification Date:
2025-12-24 @ 4:19 PM
NCT ID:
NCT02785666
Eligibility Criteria:
Inclusion Criteria:
* Informed consent documented by signature
* Participation in the SHCS
* Male individual ≥18 years old
* Homosexual or bisexual preference/transmission mode according to the SHCS entry state and/or in the opinion of the study physician.
* Replicating HCV infection (i.e., positive HCV-RNA-test).
* HCV GT 1 and/or 4 infection.
Exclusion Criteria:
* Contraindications to grazoprevir/elbasvir and ribavirin due to significant drug-drug interactions (DDI) (e.g., HIV protease inhibitors) according to the Liverpool drug-interaction data base.
* Contraindications to grazoprevir/elbasvir and ribavirin, e.g. known hypersensitivity or allergy to the class of drugs or the investigational product.
* Participant is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
* Inability to follow the study procedures (e.g. language barriers, psychiatric disorders
* Known or suspected non-adherence to study-procedures.
* Currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study.
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
* Participant suffers from clinically significant concomitant diseases (for the detailed list of diseases we refer to the according section of this protocol).
* Participant has a history of malignancy ≤5 years prior to signing informed consent or is under evaluation for other active or suspected malignancy.
* Participant has a history of opportunistic infection in the preceding 6 months prior to screening.
* Participants with mixed HCV infection of genotype 1, 4 or 6 with genotype 2, 3 or 5.
* Participant is coinfected with HBV-DNA positive hepatitis B virus (of note, HBsAg positive individuals with suppressed HBV-DNA might be included).
* Participant has evidence of decompensated liver disease.
* Liver cirrhosis Child-Pugh Class B or C, or who have a Pugh-Turcotte (CPT) score \>5,
* Participant has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
* Participant has clinically-relevant drug or alcohol abuse at the PI's discretion within 12 months of screening.
* Participant is a male whose female partner(s) is/are pregnant (this is a contraindication for ribavirin use)
* Participant has exclusionary laboratory values at the screening visit (for the table containing these laboratory values we refer to the according section of this protocol).
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02785666
Study Brief:
Protocol Section:
NCT02785666