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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT01516918
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have genotype 1 Chronic Hepatitis C
* Subjects must have compensated cirrhosis
* Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
* Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
Exclusion Criteria:
* Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
* Any contraindication to Peg-IFN or RBV therapy
* Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
* A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01516918
Study Brief:
Protocol Section:
NCT01516918