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Prognostic Model of HCV-related Disease Progression After DAAs

Sponsor
Peking University People's Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04631640
Collaborator
(none)
234
Enrollment
49
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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
    Anticipated Enrollment :
    234 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Prognostic Model of HCV-related Disease Progression After DAAs
    Anticipated Study Start Date :
    Dec 1, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2022
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    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;

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Peking University People's Hospital

    Investigators

    • Principal Investigator: Huixin Liu, Ph.D., Peking University People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Liu Huixin, Assistant professor, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT04631640
    Other Study ID Numbers:
    • PHSC-1
    First Posted:
    Nov 17, 2020
    Last Update Posted:
    Nov 17, 2020
    Last Verified:
    Nov 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Liu Huixin, Assistant professor, Peking University People's Hospital
    HCV
    Additional relevant MeSH terms:
    Disease Progression

    Study Results

    No Results Posted as of Nov 17, 2020