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 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT00726557
Eligibility Criteria:
Inclusion Criteria:
* Treatment-naïve participants or relapsers to interferon monotherapy
* Participants with chronic hepatitis C infection
* At least 18 years of age
* Must meet the following laboratory criteria:
* Platelets \>=100,000/mm\^3
* Neutrophil count \>=1,500/mm\^3
* TSH (thyroid stimulating hormone) within normal limits
* Hemoglobin \>=12 g/dL (females); \>=13 g/dL (males)
* Ex-intravenous drug abusers who are under stable substitution therapy
* Women of childbearing potential must practice adequate contraception and have a routine pregnancy test performed monthly during treatment and for 7 months post-treatment.
* Sexually-active participants must be practicing acceptable methods of contraception during the treatment and for 7 months post-treatment
Exclusion Criteria:
* Any contraindications specified in the SPC (Summary of Product Characteristics) and approved European labeling
* Hypersensitivity to the active substance or to any interferons or to any of the excipients
* Pregnant women
* Women who are breast-feeding
* Existence of or history of severe psychiatric condition, in particular severe depression, suicidal ideation or suicide attempt
* A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months
* Severe debilitating medical conditions, including participants with chronic renal failure or creatinine clearance \<50 mL/min
* Coinfection with HIV (Human Immunodeficiency Virus)
* Autoimmune hepatitis or history of autoimmune disease
* Severe hepatic dysfunction or decompensated cirrhosis of the liver
* Pre-existing thyroid disease unless it can be controlled with conventional therapy
* Epilepsy and/or compromised central nervous system function
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00726557
Study Brief:
Protocol Section:
NCT00726557