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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT01852604
Eligibility Criteria:
Inclusion Criteria:
* Must have Genotype 1a, 1b, 4 or 6 HCV infection.
* Documented clinical history compatible with chronic hepatitis C
* HCV treatment-naïve or interferon/RBV-treatment relapsed (Part C)
* Must agree to use an acceptable double method of birth control (one of which must be a barrier method) for at least 6 months after the last dose of study drugs.
Exclusion Criteria:
* Female participants who are pregnant or breastfeeding.
* Body Mass Index (BMI) \> 36 kg/m2.
* Co-infected with hepatitis B virus or human immunodeficiency virus (HIV).
* History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC.
* History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency.
* Has one or more known primary or secondary causes of liver disease, other than hepatitis C
* History of, or active, acute or chronic, liver or biliary injury due to drugs, toxins, non-HCV viral hepatitis, gallstones or other etiologies
* Donated blood or had significant blood loss 30 days prior to dosing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01852604
Study Brief:
Protocol Section:
NCT01852604