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 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
NCT ID:
NCT01058512
Eligibility Criteria:
Inclusion Criteria:
* A serum HCV RNA level of \>100,000 IU/ml using a quantitative, branched-chain-DNA (bDNA)-based assay (lower limit of quantitation = \~650 IU/ml) or other equally sensitive quantitative methods.
* Infection with genotype 1 HCV
* Documented failure to respond to treatment (defined as a patient who did not achieve an early viral response (EVR) (≥2 log reduction in serum HCV RNA or undetectable HCV RNA after 12 weeks of treatment) OR is serum HCV RNA positive after 24 weeks of treatment with pegylated interferon plus ribavirin for hepatitis C
* Adequate laboratory parameters
* Women of childbearing potential willing to use two acceptable methods of birth control during trial participation or are sterile or post-menopausal (defined as not having a menstrual cycle for greater than two years)
* Sexually active male subjects are practicing acceptable methods of contraception during trial participation
* Have the ability to understand the requirements of the trial, have provided written informed consent, and agree to abide by the trial restrictions and to return for the required assessments
* The subject must be able to self administer daily subcutaneous injections or their caregiver must be able to administer daily subcutaneous injections
Exclusion Criteria:
* Clinical, laboratory, or histological evidence of liver cirrhosis
* Evidence of hepatic decompensation (presence of or a history of ascites, hepatic encephalopathy, variceal bleeding, or hepatocellular carcinoma)
* Co-infection with human immunodeficiency virus (HIV) or active hepatitis B virus (HBV) (as determined by presence of hepatitis B surface antigen (HBsAg)
* Have received pegylated interferon and/or ribavirin within the 60 days prior to enrollment
* Any known preexisting medical condition that could interfere with the subject's participation in and completion of the protocol
* Pregnant female or nursing mother
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01058512
Study Brief:
Protocol Section:
NCT01058512