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 @ 4:49 PM
Ignite Modification Date:
2025-12-24 @ 4:49 PM
NCT ID:
NCT02858050
Eligibility Criteria:
Inclusion Criteria:
1. Male or female 18 years old and above.
2. HCV treatment naïve or HCV trreatment experienced
3. HCV RNA PCR \> 10,000 IU/L
4. Confirmed infection with Hepatitis C virus (HCV) by HCV serum antibody assay and by HCV Ribonucleic Acid (RNA) Polymerase Chain Reaction (PCR) and Confirmed chronicity with 2 PCR's 6 months apart.
5. Patients with HCV Genotype 1, 4
6. Patients are candidates for treatment of HCV with oral Direct-Acting Agents (DAA)
7. understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent
Exclusion Criteria:
1. Patient not willing to sign written informed consent
2. Patients deemed not suitable for HCV treatment as deemed by the treating physician at the liver center
3. Patients with decompensated liver cirrhosis, defined as follows:
1. Liver biopsy within the last year showing Scheuer Stage 4 or transient elastography (Fibroscan®) in the last year with a reading of \>12.5 kPa; AND
2. Any clinical sign of hepatic decompensation such as ascites (fluid in the abdomen), jaundice (yellowing of eyes and skin), esophageal varices with bleeding (enlarged veins of the esophagus seen on endoscopy) or hepatic encephalopathy (tremors, confusion, sleepiness)
4. Co-Infection with the Hepatitis B virus
5. Any liver disease of non-HCV etiology such as Hemochromatosis, Wilson's Disease, Alcoholic liver disease or Non-Alcoholic Steato-Hepatitis (NASH)
6. Hepatocellular carcinoma or any other malignancy
7. Untreated psychiatric conditions such as major depression, schizophrenia, bipolar disorder which in the opinion of the Principal Investigator will not interfere with protocol visit and/or procedures
8. Current and untreated substance abuse (cocaine, opiates, alcohol, marijuana, other recreational drugs, controlled substances)
9. Patient is pregnant or breastfeeding.
10. Patients unwilling to use cellular phones
11. Patients unwilling to follow specific instructions for medication intake
12. Patient has any of the following conditions:
* Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
* Poor venous access that precludes routine peripheral blood sampling required for this trial.
* History of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
* History of a medical/surgical condition that resulted in hospitalization within the 3 months prior to enrollment, other than for minor elective procedures
* Medical/surgical conditions that may result in a need for hospitalization during the period of the study
* any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressant drugs during the course of the trial
13. has exclusionary laboratory values as listed below: Noncirrhotic/Cirrhotic Subjects Creatinine clearance \< 50 mL/min Hemoglobin \<9.5 g/dL for both male and female subjects Platelets \<50 x 103/μL serum albumin \< 3.0 g/dL INR \>1.7, unless subject has a stable INR on an anticoagulant regimen. HbA1c \>10% ALT \>10XULN AST \>10XULN
14. is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02858050
Study Brief:
Protocol Section:
NCT02858050