Prognostic Model of HCV-related Disease Progression After DAAs

Not yet recruiting

• Conditions: HCV

• Registration Number: NCT04631640
• Lead Sponsor: Peking University People's Hospital

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 Timeline

• Status Verified: 2020-11
• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-15
• Last Update Submitted: 2020-11-15
• Study First Posted: 2020-11-17
• Last Update Posted: 2020-11-17
• Study Start: 2020-12-01
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 234

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;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incidence of composit liver-related events	through study completion, an average of 2 year	Composite liver outcomes, including liver-related deaths, hepatocellular carcinoma, liver decompensation, or liver transplantation.