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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT02874066
Eligibility Criteria:
Inclusion Criteria:
* Ages of 20 to 70 yeas
* Male or female
* Body mass index (BMI) 18.5-35.0 kg/m2
* Chronic HCV infection, defined as patients who meet as least one of the two following criteria
1. Anti-HCV antibody (Abbott HCV enzyme-linked immunosorbent assay \[EIA\] 2.0, Abbott Laboratories, Abbott Park, Illinois, USA) or HCV RNA \> 1,000 IU/mL for at least 6 months before screening
2. Positive HCV RNA \> 1,0000 IU/mL (Cobas TaqMan HCV Test v2.0, Roche Diagnostics Gesellschaft mit beschränkter Haftung \[GmbH\], Mannheim, Germany, low limit of quantification (LLOQ): 25 IU/mL) at the time of screening with a liver biopsy consistent with chronic HCV infection
* HCV GT-1b infection (Abbott RealTime HCV genotyping II, Abbott Molecular Inc. Illinois, USA)
* Treatment-naïve or treatment-experienced (including patients who relapsed, who had virological breakthrough, or who were null-responsive to IFN-based therapies)
* HCV RNA \> 10,000 IU/mL at screening
* Absence of cirrhosis with documented results of one of the following criteria:
1. Liver biopsy within 24 months prior to or during screening demonstration the absence of cirrhosis, e.g. METAVIR score ≤ 3 or Ishak score ≤ 4.
2. A screening transient elastography (Fibroscan) result of \< 12.5 kilopascal (kPa)
3. A screening Fibrosis Index Based on 4 markers (FIB-4) of ≤ 1.45 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) of ≤ 2
4. Subjects with non-qualifying FIB-4/APRI or Fibroscan result may only be enrolled if they have a qualifying liver biopsy within 24 months prior to or during screening
* Estimated glomerular filtration (eGFR) rate \< 15 mL/min/1.73m2 as assessed by modified of diet in renal disease (MDRD) equation, and receiving regular hemodialysis
Exclusion Criteria:
* HCV infection other than HCV GT-1b
* Hepatitis B virus (HBV) or HIV co-infection
* Presence of cirrhosis (Child-Puge class A, B or C)
* Any primary cause of liver disease other than chronic HCV infection, including but not limited to the following
1. Hemochromatosis
2. Alfa-1 antitrypsin deficiency
3. Wilson's disease
4. Autoimmune hepatitis
5. Alcoholic liver disease
6. Drug-induced hepatitis
* Screening laboratory analyses showing any of the following results
1. Hemoglobin (Hb) level \< 10 g/dL
2. Absolute neutrophil count (ANC) \< 1,500 cells/μL
3. Platelet count \< 60,000 cells/mm3
4. International normalized ratio (INR) \> 2.0
5. Albumin (Alb) \< 2.8 g/dL
6. Bilirubin (Bil) \> 3.0 mg/dL
7. Alanine aminotransferase (ALT) \> 5X upper limit of normal (ULN)
8. Aspartate aminotransferase (AST) \> 5X upper limit of normal (ULN)
9. Serum alfa-fetoprotein (AFP) \> 100 ng/mL
* Presence of hepatocellular carcinoma (HCC) on imaging studies such as computed tomography (CT) scan or magnetic resonance imaging (MRI)
* History of malignancy (except cutaneous melanoma) within 5 years at the screening
* Organ transplantation other than cornea and hair (prior renal transplantation with graft failure not included)
* Prior exposure to investigational agents for HCV (direct acting antiviral agents, host-targeting agents, or therapeutic vaccines)
* Pregnancy
* Unwilling to have contraception during the study period \[12\] Unwilling to provide informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02874066
Study Brief:
Protocol Section:
NCT02874066