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 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT02597166
Eligibility Criteria:
Inclusion Criteria:
Treatment-naïve and treatment-experienced patients with CHC genotype 1 infection and decompensated cirrhosis as defined by one of the following:
* history of variceal bleeding
* presence or history of ascites
* history of grade III-IV hepatic encephalopathy
* Coagulopathy with an INR\>1.7
* Jaundice with a serum bilirubin of \>85µmol/L
Cirrhosis is defined as any one of the following:
* A liver biopsy performed prior to the study showing cirrhosis (F4)
* Fibroscan performed within 12 calendar months of the start of this study with a result of \> 12.5 kPa
* A Fibrotest ® score of \>0.75
Exclusion Criteria:
* Patients older than 75 years
* Presence of hepatoma at entry
* Patients awaiting living-related liver transplantation
* MELD score of \>30
* Significant co-morbid condition(s) with a life expectancy of \<6 months
* HIV co-infection
* HBV co-infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02597166
Study Brief:
Protocol Section:
NCT02597166