ong-term hepatic and extra-hepatic outcomes of CHC patients post sofosbuvir-based IFN-free treatment
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0003269
- Lead Sponsor
- Asan Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 200
For Sofosbuvir-based therapy observational group:
•Patients = 20 of years who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643)
•Patients who had received at least one dose of sofosbuvir-based therapy in the parent studies.
Who IFN-based therapy historical controls, matched with sex, age, level of liver fibrosis and virological response:
•Patients = 20 of years who had received pegylated interferon plus ribavirin therapy with match of sex, age, level of liver fibrosis and virological response
•Patients who have ever participated study will be collected as historical control.
For Sofosbuvir-based therapy observational group:
•Patients < 20 of years
•Patients who are unwilling to participate the current study
•Patients who had never participated in parent studies, GS-US-337-0131 (NCT02021656) nor GS-US-334-0115 (NCT02021643)
•Patients who had never received at least one dose of sofosbuvir-based therapy in the parent studies.
Who IFN-based therapy historical controls:
•Patients < 20 of years
•Patients who are unwilling to participate the current study
•Patients who had never received pegylated interferon plus ribavirin therapy
•Patients who did not participate study
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment;Number of participants with liver-related mortality development during 5-year follow-up period after sofosbuvir-based treatment;Number of participants with hepatocellular carcinoma (HCC) development during 5-year follow-up period after sofosbuvir-based treatment
- Secondary Outcome Measures
Name Time Method ife quality;Cryoglobulinemia;Diabetes mellitus;Insulin resistance;Lipid profiles(triglyceride(TG), cholesterol(Chol), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C));Renal disease