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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02823457
Eligibility Criteria:
Inclusion Criteria:
1. Identified as having treatment-naïve genotype 1 chronic HCV infection; Veterans who are genotype 1a must have baseline NS5a resistance testing
2. Current resident of the SARRTP program
3. Willing to initiate treatment with FDC MK-5172/MK-8742 during SARRTP and up to 30 days post-discharge.
4. Willing to attend coordinated HCV treatment clinic visits and substance abuse aftercare visits every 2 weeks upon SARRTP discharge
Exclusion Criteria:
1. Contraindications for therapy with FDC MK-5172/MK-8742
2. Unable to provide written informed consent
3. Hepatocellular carcinoma or other medical condition precluding HCV treatment
4. Acute HCV infection
5. Prior treatment for chronic HCV
6. History of decompensated cirrhosis
7. Platelet count \< 75 K/cmm and/or albumin \< 3 grams/dL
8. Females and male sex partners of females who are pregnant, nursing and/or unwilling to use contraception
9. Patients infected with genotype 1a who have not undergone baseline NS5a resistance testing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02823457
Study Brief:
Protocol Section:
NCT02823457