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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06325826
Other study ID # GES
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date June 30, 2025

Study information

Verified date March 2024
Source Egyptian Liver Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This cohort study aims to evaluate the validation of general evaluation score in the prediction of hepatocellular carcinoma risk among patients with advanced fibrosis (F3) and cirrhosis (F4) who achieved sustained virological response for hepatitis c virus after direct acting antiviral drugs and determine the group of these patients who require intensified surveillance.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 500
Est. completion date June 30, 2025
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patients aged 18 years or older. - Patients with compensated advanced chronic liver disease (cACLD) according to Baveno VI consensus (F3-F4) - achieved SVR for HCV after DAAs. Exclusion Criteria: - Previous interferon (IFN) treatment. - Hepatitis B virus (HBV) or human immune-deficiency virus (HIV) co-infection. - Current hepatocellular carcinoma (HCC) or other malignancies. - Previous history of HCC or HCC intervention. - Liver cell failure, liver transplantation or renal impairment

Study Design


Intervention

Diagnostic Test:
General Evaluation Score (GES)
According to Evaluation of GES scores Patient will be classified into three groups based on GES score low risk group (score =6 points), intermediate risk group (score 6-7.5 points), and high-risk group (score >7.5 points)

Locations

Country Name City State
Egypt Egyptian Liver Hospital Talkha Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Egyptian Liver Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hepatocellular Carcinoma Number of Participants develop New Hepatocellular Carcinoma 24 month
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