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:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
NCT ID:
NCT00423800
Eligibility Criteria:
Inclusion Criteria:
* Must demonstrate willingness to participate in the study.
* Diagnosed with chronic HCV.
* Between 18 and 65 years of age of either gender and of any race.
* a. HCV positive, \>600,000 IU/mL at baseline AND b. Genotype 1.
* Suitable for treatment with Pegetron® per the Canadian product monograph.
* Investigator has already decided to treat with PEGETRON REDIPEN®
1.5mcg/kg/week of peginterferon alpha-2b plus 800-1200 mg /day of ribavirin.
* HCV-RNA negative at treatment week 4.
* Meet certain minimum laboratory values at the week 4 screening visit.
* Women of childbearing potential and male partners must agree to use a medically accepted method of contraception prior to screening, while receiving protocol-specified medication, and for 6 months after stopping the medication. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, oral or injectable hormonal contraceptive, and surgical sterilization (e.g. hysterectomy or tubal ligation).
Exclusion Criteria:
* Had previous interferon-based therapy for Chronic Hepatitis C.
* Active Hepatitis B virus (HBV) infection.
* Human Immunodeficiency Virus (HIV) antibody positive.
* Cirrhotic (Stage 4 on Metavir system).
* Uncontrolled history or current severe depression or psychoses.
* Uncontrolled epilepsy.
* Use of illicit drugs.
* History of non-compliance to medical regimens.
* Liver disease other than from chronic hepatitis C.
* Participating in any other clinical study.
* Used any investigational drugs within 30 days of screening.
* Participants weighing \< 40 kg or \> 125 kg.
* Pregnant women or women who plan to become pregnant or sexual partners of women who want to become pregnant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT00423800
Study Brief:
Protocol Section:
NCT00423800