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:
2025-12-25 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT01889433
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent to participate in the study.
2. Chronic HCV infection (genotypes 1а, 1b, 2, 3, 4) with detectable HCV RNA \>6 month before the screening visit or abnormal ALT levels for \>6 month before the screening visit.
3. Male and female patients, 18 to 70 years of age, inclusive.
4. Body mass index of 18 - 30 kg/m2.
5. Preserved protein synthetic liver function (INR \< 1.7, albumin \> 35 g/l).
6. No signs of hepatic encephalopathy or abdominal fluid retention according to clinical and ultrasound examination.
7. Fertile patients and their partners agree to use barrier contraception throughout the study treatment and 7 months after it.
8. Patient must have documentation of fibroscan within 1 year before the screening visit or agree to have a fibroscan within the screening period.
Exclusion Criteria:
1. Intolerance to IFN alfa, ribavirin or any components of this preparations confirmed by past medical history.
2. Infection by hepatitis B, A, E virus or HIV (co-infection).
3. Any other documented significant liver disease (drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, biliary cirrohosis, etc.).
4. Past history of HCV treatment with IFN alfa or pegylated IFN alfa.
5. Administration of injectable and non-injectable interferons and/or some interferon inducers for any indication (other than HCV) for one month before enrollment into the study.
6. Cholestatic hepatitis (level of conjugated bilirubin, alkaline phosphatase, G-GTP exceeding the upper normal level by more than 5 times).
7. Decompensated liver cirrhosis confirmed by laboratory findings (class B, С according to Child-Pugh) or ultrasound examination.
8. Any documented autoimmune diseases (e.g., Crohn's disease, ulcerative colitis, systemic lupus erythematosus, idiopathic thrombocytopenic purpura, scleroderma, autoimmune haemolytic anemia, severe psoriasis).
9. Hemoglobin not lower than low normal level; neutrophils \< 1.5 х109/L; platelets \< 90 х109/L; creatinin level exceeding the upper normal level by more than 1.5 times, ALT level exceeding the upper normal level by more than 10 times.
10. Documented hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia).
11. Severe depression, schizophrenia, other mental disorders, which from the investigator's point of view are a contraindication for anti-viral treatment.
12. Epilepsy and/or disorder of function of the central nervous system.
13. Abnormal thyroid function (TTH level beyond the normal values).
14. Diagnosed or suspected hepatocellular carcinoma as evidenced by screening alfa-fetoprotein (AFP) of ≥ upper normal level.
15. Antinuclear antibody (ANA) titer ≥1:640 at screening and/or evidence of autoimmune hepatitis on liver biopsy.
16. Malignant neoplasms.
17. Pregnancy, lactation period.
18. Severe comorbidities (for example, severe hypertension, severe coronary heart disease, decompensated diabetes mellitus) that represent a contraindication for anti-viral treatment.
19. Documented rare hereditary diseases, such as intolerance of lactose, sucrose, fructose, lactase deficiency or glucose-galactose malabsorption.
20. Known drug or alcohol abuse or signs of drug/alcohol abuse in present, which from the investigator's point of view are a contraindication for anti-viral treatment or restrict adherence to the treatment regimen.
21. Simultaneous participation in other clinical studies less than 30 days before enrollment into this study or previous participation in this clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01889433
Study Brief:
Protocol Section:
NCT01889433