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 @ 1:27 PM
Ignite Modification Date:
2025-12-24 @ 1:27 PM
NCT ID:
NCT00724295
Eligibility Criteria:
Inclusion Criteria:
Patients with chronic hepatitis C.
* Patients are serogroup 1(genotype I (1a) or II (1b)).
* The HCV-RNA level in the blood is more than 10\^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method
Exclusion Criteria:
* Patients with a history of hypersensitivity to test drugs or other interferon preparations
* Patients with a history of hypersensitivity to biological products, such as vaccines
* Patients being treated with Shosaikoto
* Patients with autoimmune hepatitis
* Pregnant women, women who may be pregnant, and nursing mothers
* Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
* Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
* Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
* Patients with chronic renal failure or renal function disorder with creatinine clearance of \<=50 mL/min
* Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
* Patients with serious hepatic dysfunction
* Patients with autoimmune hepatitis
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00724295
Study Brief:
Protocol Section:
NCT00724295