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:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT01241760
Eligibility Criteria:
Inclusion Criteria:
* Patient has chronic HCV infection genotype 1 with HCV RNA level \> 1,000 IU/mL
* Patients should not have had any previous treatment for hepatitis C
* Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
* Patients with cirrhosis should have serum alpha-fetoprotein (AFP) \<= 50 ng/mL. If AFP \> 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
* A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.
Exclusion Criteria:
* Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
* Patient has a pre-existing psychiatric condition
* Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
* Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
* Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01241760
Study Brief:
Protocol Section:
NCT01241760