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Long Term Follow up of Chronic HCV Patients Receiving DAAS

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05170490
Collaborator
(none)
100
Enrollment
1
Location
57
Anticipated Duration (Months)
1.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Follow up of Chronic hepatitis C Patients with moderate to severe fibrosis and cirrhosis treated with Direct Acting Antivirals after Sustained Virological Response for 4-5 years to detect changes in hepatic fibrosis and liver functions.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Treatment of chronic hepatitis C is evolving rapidly. Three classes of direct-acting antiviral agents, including inhibitors of the HCV NS3/4A protease, NS5B polymerase, and NS5A have been approved for the treatment of patients with chronic hepatitis C, both in combination with pegylated Interferon (Peg-IFN) / ribavirin (RBV) and, recently, in interferon-free combination.

    The objective of chronic hepatitis C treatment is to achieve SVR which is defined as the absence of viral replication at 12 or 24 weeks after treatment completion. SVR reduces morbidity and mortality and is equivalent in most cases to cure the HCV infection. Studies have demonstrated that SVR is associated with histological improvement, assessed by liver biopsy, and with the prevention of complications, such as the development of liver cirrhosis and HCC.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Long Term Follow up of Chronic Hepatitis C Patients Treated With Direct Acting Antivirals After Sustained Virological Response
    Actual Study Start Date :
    Jun 1, 2018
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Mar 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. changes in hepatic fibrosis [4 years after end of treatment]

      Shear wave elastography

    Secondary Outcome Measures

    1. change in serum albumin level [4 years after end of treatment]

      change in liver function

    2. change in prothrombin level [4 years after end of treatment]

      change in liver function

    3. change in bilirubin level [4 years after end of treatment]

      change in liver function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Chronic HCV patients with moderate to severe hepatic fibrosis (F2: F4) or cirrhosis who received direct-acting antivirals and achieved SVR.
    Exclusion Criteria:
    • Other liver diseases as Chronic hepatitis B and autoimmune liver disease. HIV co-infection.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospital Sohag Egypt

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amira Maher, Lecturer, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05170490
    Other Study ID Numbers:
    • DAAS in HCV patients
    First Posted:
    Dec 28, 2021
    Last Update Posted:
    Jun 30, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis C
    Hepatitis C, Chronic
    Hepatitis
    Hepatitis, Chronic

    Study Results

    No Results Posted as of Jun 30, 2022