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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT01528735
Eligibility Criteria:
Inclusion criteria:
* Chronic hepatitis C, diagnosed by positive anti-hepatitis C virus(HCV) antibodies and detected HCV ribonucleic acid(RNA) at screening in addition to:
1. positive anti-HCV antibodies or detected HCV RNA at least 6 months prior to screening; or,
2. liver biopsy consistent with chronic HCV infection.
* HCV infection of genotype 1 confirmed by genotypic testing at screening
* Therapy-naïve to interferon, pegylated interferon, ribavirin or any antiviral / immunomodulatory drug for acute or chronic HCV infection.
* Plasma HCV RNA = 100,000 IU/mL at screening
Exclusion criteria:
* Hepatitis C infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening
* Human immunodeficiency virus (HIV) co-infection
* Decompensated liver disease, or history of decompensated liver disease
* Body weight \< 40 or \> 125 kg at screening
* Hemoglobin \<12.0g/dL for women and \<13.0g/dL for men at screening
* White blood cell count \<3000 cells/mm3 at screening
* Absolute neutrophil count \< 1,500 cells/mm3 at screening
* Platelet count \< 90,000 /mm3 at screening
* Serum creatinine \> 1.5xUpper Limit of Normal range(ULN) or creatinine clearance =50 mL/min at screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01528735
Study Brief:
Protocol Section:
NCT01528735