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

Completed

• Conditions: HCC

• Registration Number: NCT04173520
• Lead Sponsor: Egyptian Liver Hospital

Brief 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).

Detailed 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).

Study Timeline

• Study Start: 2015-01
• Primary Completion: 2019-08
• Study Completion: 2019-10-30
• Status Verified: 2019-11
• Study First Submitted: 2019-11-17
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-22
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2326

Inclusion Criteria

• no history of previous HCC
• SVR after DAAs treatment

Exclusion Criteria

• history of previous HCC

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of HCC incidence after viral clearance	12-45 months after SVR