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NCT04173520 Clinical Trial

ELRIAH Score: A Simple Score for HCC Risk Stratification in CHC Patients With Cirrhosis or Advanced Liver Fibrosis Who Achieved SVR Following DAA Therapy

HCC Clinical Trial

Official title:
ELRIAH Score: A Simple Score for HCC Risk Stratification in CHC Patients With Cirrhosis or Advanced Liver Fibrosis Who Achieved SVR Following DAA Therapy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04173520
Other study ID # SCORE
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2015
Est. completion date October 30, 2019

Study information
Verified date November 2019
Source Egyptian Liver Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).

Description:

Current guidelines recommend biannual surveillance for hepatocellular carcinoma (HCC) in all patients with cirrhosis. However, risk of HCC incidence is not the same for different patients. The study aimed to develop a scoring system to assess risk of developing HCC in a large cohort of chronic hepatitis C (CHC) patients with advanced hepatic fibrosis (F3) or cirrhosis (F4) with sustained virological response (SVR) after receiving direct acting antivirals (DAAs).

Recruitment information / eligibility
Status Completed
Enrollment 2326
Est. completion date October 30, 2019
Est. primary completion date August 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- no history of previous HCC

- SVR after DAAs treatment

Exclusion Criteria:

- history of previous HCC

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DDA
Follow up after SVR

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Egyptian Liver Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of HCC incidence after viral clearance 12-45 months after SVR
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