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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT00856804
Eligibility Criteria:
Inclusion Criteria:
* Men and women in non fertile age.
* HCV RNA detectable in serum.
* Chronic hepatitis C virus with non-cirrhotic compensated liver disease (clinical classification according to Child-Pugh Grade A) (Appendix 1).
* Genotype 1.
* Not responding to treatment with peginterferon alfa-2a in combination with Ribavirin.
* Effective contraceptive measures during treatment and for 6 months after treatment.
Exclusion Criteria:
Patients with any of the following will not be selected for treatment:
* Patients with liver biopsy compatible with cirrhosis F4 Metav classification.
* Patients diagnosed with diabetes or basal glycemia higher than 126 mg / dl
* Women and men of childbearing age
* Treatment with systemic antineoplastic or immunomodulatory (including suprafisiológicas doses of steroids and radiotherapy) 6 months before the first dose of treatment.
* Treatment with any investigational drug 6 weeks before the first dose of treatment.
* History or other evidence of any pathology associated with chronic liver disease than HCV.
* Signs or symptoms of hepatocellular carcinoma.
* History or other evidence of bleeding due to esophageal varices or other conditions consistent with decompensated liver disease.
* neutrophil count \<1500 células/mm3 or platelet count \<90,000 células/mm3 at Screening.
* Hb \<12 g / dL in women or \<13 g / dL in men, at the time of evaluation.
* Patients with baseline increased risk of anemia (eg thalassemia, spherocytosis, history of gastrointestinal bleeding, etc.). Or where the presence of anemia would be a medical problem.
* Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be treated if in the opinion of the investigator, could not tolerate an adequately sharp decline in hemoglobin.
* serum creatinine\> 1.5 times above the normal upper limit at the time of valuation.
* History of severe psychiatric illness, particularly depression. Is defined as a serious psychiatric illness requiring treatment with antidepressants or major tranquilizers in therapeutic doses required for major depression or psychosis, respectively, for at least 3 months at any time before or any of the following background: attempted suicide, hospitalization due to of psychiatric illness, or period of disability due to psychiatric illness.
* History of seizure disorder or current use of major anticonvulsants.
* History of immune disease, chronic lung disease associated with limited functionality, serious heart disease, congestive heart failure, advanced atherosclerosis, increased organ transplant or other signs of serious disease, neoplasia, or any other condition deemed by the investigator, prevent the patient is suitable for the study.
* A history of thyroid disease poorly controlled with medications prescribed, elevated concentrations of thyroid stimulating hormone (TSH) with increased thyroid peroxidase antibodies and any clinical manifestation of thyroid disease.
* Pathology involving a risk of acute renal function: dehydration (diarrhea, vomiting), fever, infectious states and / or hypotonic severe (shock, sepsis, urinary infection, neuropathy).
* Evidence of severe retinopathy (eg CMV retinitis, macular degeneration).
* Exploration programanada radiation with intravenous administration of contrast media (IVU, angiography).
* Evidence of drug use in the year prior to study.
* Consumption of alcohol.
* Inability or unwillingness to give informed consent or to comply with the requirements of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT00856804
Study Brief:
Protocol Section:
NCT00856804