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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT01479868
Eligibility Criteria:
Inclusion Criteria:
* A liver biopsy required within 3 years prior to screening unless the patient has a contraindication for a liver biopsy
* Patients with bridging fibrosis or cirrhosis and without a liver biopsy result within 2 years prior screening must have an ultrasound taken within 2 months prior to the screening visit or during screening with no findings suspicious for hepatocellular carcinoma (HCC)
* Genotype-1 hepatitis C virus (HCV) infection
* Plasma HCV ribonucleic acid (RNA) of more than 10,000 IU per mL
* Documented human immunodeficiency virus-type 1 (HIV-1) infection at least 6 months prior to screening
Exclusion Criteria:
* Patient showing evidence of hepatic decompensation (ie, history or current evidence of ascites, bleeding varices or hepatic encephalopathy, albumin serum concentration less than 3.3 gm per dL, prolonged prothrombin time \[PT\] expressed as international normalized ratio \[INR\] more than 1.5)
* Any liver disease of non-HCV etiology
* Co-infection with hepatitis B virus (hepatitis B surface antigen \[HBsAg\] positive)
* An acute HIV-1 infection; or HIV-2 infection
* Change in antiretroviral (ARV) regimen within the last 4 weeks prior screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01479868
Study Brief:
Protocol Section:
NCT01479868