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 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01197157
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 and \<60.
* Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system.
* Compensated liver disease; serum bilirubin \< 1.5 mg/dl, INR no more than 1.5, serum albumin \> 3.4, platelet count \>75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites).
* Acceptable hematological and biochemical indices (hemoglobin 13g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine \<1.5 mg/dl.
* Willing to be treated and to adhere to treatment requirements
Exclusion Criteria:
* Major uncontrolled depressive illness.
* Solid organ transplantation.
* Autoimmune conditions, known to be exacerbated by peginterferon and ribavirin.
* Untreated thyroid disease.
* Pregnant or unwilling to comply with adequate contraception.
* Severe concurrent medical disease such as severe hypertension, heart failure, significant coronary heart disease, poorly controlled diabetes, chronic obstructive pulmonary disease.
* Known hypersensitivity to drugs used to treat HCV.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01197157
Study Brief:
Protocol Section:
NCT01197157