Prognostic Model of HCV-related Disease Progression After DAAs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 234
- Primary Endpoint
- incidence of composit liver-related events
Study Overview
Brief Summary
In this study, the investigator would conduct an ambispective cohort study to build a prediction model of HCV-related disease after DAAs.
Detailed Description
The emergence of direct antiviral agents (DAAs) makes it possible to cure HCV, and the sustained virological response (SVR) rate is up to 90% after DAAs therapy. However, the acquisition of SVR does not mean the cure of HCV-related diseases, some patients still developed liver cirrhosis, liver cancer and other diseases after achived SVR by DAAs therapy.In this study the investigator would like to bulid a prediction model of HCV-related disease after DAAs by conducting an ambispective cohort study. The participants of this study would be adult patients (≥18 years old) with chronic HCV infection and have received DAA therapy, the investigator would retrospectively collected DAA therapy-related information, and follow-up all the enrolled participants every 6 months to observe their liver-related disease outcomes (composite liver outcome, including liver-related deaths, hepatocellular carcinoma, liver decompensation, and liver transplantation).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •adult patients (≥18 years old) with chronic HCV infection that were HCV RNA positive;
- •have received DAA treatment;
- •would like to adhere to the follow-up
Exclusion Criteria
- •lack of HCV treatment information;
Outcomes
Primary Outcomes
incidence of composit liver-related events
Time Frame: through study completion, an average of 2 year
Composite liver outcomes, including liver-related deaths, hepatocellular carcinoma, liver decompensation, or liver transplantation.
Secondary Outcomes
No secondary outcomes reported
Investigators
Liu Huixin
Assistant professor
Peking University People's Hospital