Prognostic Model of HCV-related Disease Progression After DAAs

HCV Clinical Trial

Official title:

Prognostic Model of HCV-related Disease Progression After DAAs

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04631640
• Other study ID #: PHSC-1
• Status: Not yet recruiting
• Start date: December 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2020
• Source: Peking University People's Hospital
• Contact: Huixin Liu, Ph.D.
• Phone: 15810994780
• Email: lhxepi[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, the investigator would conduct an ambispective cohort study to build a prediction model of HCV-related disease after DAAs.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 234
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Disease Progression
• HCV

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of composit liver-related events	Composite liver outcomes, including liver-related deaths, hepatocellular carcinoma, liver decompensation, or liver transplantation.	through study completion, an average of 2 year