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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT01447420
Eligibility Criteria:
Inclusion Criteria:
* Adult patients, \>/=18 and \<70 years of age at initiation of treatment
* Body weight between 50 kg and 125 kg at baseline
* Chronic hepatitis C, genotype 1
* Chronic liver disease consistent with HCV infection
* Compensated liver disease (Child-Pugh Grade A)
Exclusion Criteria:
* Pregnant or lactating women, and male partners of pregnant women
* Chronic hepatitis C, genotype 2, 3, 4, 5 or 6
* Previous treatment with interferon or ribavirin
* Positive for hepatitis A, hepatitis B or HIV infection
* History or evidence of a medical condition associated with liver disease other than chronic hepatitis C
* Decompensated liver disease and/or liver disease Child-Pugh classification \>6
* Hepatocellular carcinoma
* History or evidence of esophageal bleeding
* Hemoglobinopathy, or any other cause for possible hemolysis
* Hb \<11 g/dL in women, \<12 g/L in males
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
69 Years
Study:
NCT01447420
Study Brief:
Protocol Section:
NCT01447420