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 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT00882193
Eligibility Criteria:
Inclusion Criteria:
* Subject must be willing to give informed consent and be able to adhere to dose and visit schedules.
* History of chronic hepatitis C, genotype 1, non-responders or relapsers as documented by genotype testing and HCV RNA levels at 12 weeks ( \< 2 log change) during therapy or at 3 - 12 months post therapy, respectively.
* Adult subjects 18-70 years of age, of either gender
* Liver biopsy within 3 years prior to the screening 1 visit with a pathology report confirming that the histological diagnosis is consistent with chronic hepatitis C.
* Compensated liver disease with the following maximum hematologic, biochemical and serologic criteria at the Screening visit (WNL=within normal limits) Hemoglobin \> 12 g/dl for females and \>13 g/dl for males, WBC \> 3000/mm3, Platelets \> 80,000/mm3, Direct Bilirubin - WNL. Indirect bilirubin - WNL, Albumin - WNL, Serum Creatinine - WNL.
* Fasting glucose should be 70 -140 mg/dl, results between 116-140 require a HbA1c \< 8.5%
* TSH - WNL
* Subjects with a history of mild depression may be considered for entry in to this study provided that a pretreatment assessment of the subject's affective status supports that the subject is clinically stable.
* Subjects with a history of substance abuse must have abstained from using the substance for at least one year prior to the Screening visit.
* Antinuclear antibodies (ANA) \< 1:320
* No radiologic evidence of a focal mass suggestive of hepatoma and/or ascites.
Exclusion Criteria:
* Pregnant or nursing subjects. Subjects who intend to become pregnant during the study period. Subjects with partners who intend to become pregnant during the study period.
* Prior response to therapy and failure to achieve SVR which may have been due to treatment non-compliance, in the assessment of the investigator based upon subject's medical history.
* Participation in any clinical trial of a HCV protease inhibitor of any duration. Subjects may have received other investigational agents for the treatment of HCV, as long as they have also received an adequate course of Peg-IFN/RBV \[i.e., the investigational agent could not have replaced either Peg-IFN (such as Albuferon) or RBV (viramidine)\].
* History of new hepatitis C exposure within the last 6 months
* Current or intended use of G-CSF and/or GM-CSF during the stud period is prohibited. Current use of erythropoietin (EPO) is prohibited.
* Suspected hypersensitivity to any interferon product or ribavirin
* Participation in any other clinical trial within 30 days of Screening visit 1
* Treatment with any investigational drug within 30 days of Screening visit 1.
* Any other cause for liver disease other than CHC, including but not limited to: hemachromatosis, Alpha-1 antitrypsin deficiency, Wilson's disease, Autoimmune hepatitis, Alcoholic liver disease, Non-alcoholic steatohepatitis (NASH), Drug-related liver disease
* Known coagulopathies including hemophilia
* Known hemoglobinopathies
* Known G6PD deficiency
* Known coinfection with HIV and/or HBV
* Evidence of active or suspected malignancy or a history of malignancy within the last five years (with the exception of adequately treated basal cell carcinoma of the skin).
* Evidence of decompensated liver disease such as history or presence of ascites, bleeding varices or hepatic encephalopathy
* Subjects with organ transplants other than cornea or hair transplant
* Any Known preexisting medical condition, that could interfere with the subject's participation in and completion of the study including, but not limited to moderate to severe depression, or a history of severe psychiatric disorder, such as psychosis, suicidal ideation and/or suicidal attempt; Subjects with a past history or current use of lithium and/or antipsychotic drugs; CNS trauma or seizure disorder; Clinically significant ECG abnormalities and/or significant cardiovascular dysfunction within the past 2 years prior to Screening ; Poorly controlled diabetes mellitis; Chronic pulmonary disease (COPD); Immunologically mediated disease such as inflammatory bowel disease, rheumatoid arthritis, idiopathic thrombocytopenia purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis or symptomatic thyroid disorder; Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids: History of, or active clinical gout.
* Substance abuse, such as alcohol (\>80 g/day), IV drugs and inhaled drugs. Subjects with a history of substance abuse must have abstained from the abuse substance for at least one year. Subjects with clinically significant retinal abnormalities
* Any other condition which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol
* Subjects who are part of the staff personnel directly involved with the study
* Subjects who are immediate family members of the investigational study staff
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT00882193
Study Brief:
Protocol Section:
NCT00882193