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 @ 10:44 PM
Ignite Modification Date:
2025-12-24 @ 10:44 PM
NCT ID:
NCT01432535
Eligibility Criteria:
Inclusion Criteria:
* Body Mass Index (BMI) between 19 to 40 kg/m\^2, inclusive
* Moderate renal impairment and severe renal impairment and/or end-stage renal disease (ESRD) who may require hemodialysis and normal renal function
* Free of any clinically significant disease (except those related to renal disease and comorbid conditions) that requires a physician's care and would interfere with the study
* Females of reproductive potential must have used a medically accepted method of contraception for three months prior to screening and must agree to use an accepted contraceptive method during and for two months following the study
* Males must agree to use a medically accepted method of contraception during the trial and for 3 months after the study
Exclusion Criteria:
* Pregnant, intend to become pregnant, or breastfeeding
* Surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug
* History of any infectious disease within 4 weeks prior to study drug administration that affects ability to participate in the study
* Positive for hepatitis B surface antigen, and/or for human immunodeficiency virus (HIV) antibodies. Healthy participants positive for hepatitis C antibodies
* Previously received PegIntron®, Sylatron®, and/or Pegasys
* More than 10 cigarettes or equivalent tobacco use per day
* History of malignancy
* Hypothyroidism or hyperthyroidism
* History of depression requiring treatment with psychotherapy or medication
* History of suicidality or at risk of self-harm or harm to others
* History of autoimmune disorder requiring medical therapy
* Immune mediated renal insufficiency
* Removal of a kidney (healthy participants) or functioning renal transplant (participants with renal impairment)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT01432535
Study Brief:
Protocol Section:
NCT01432535