ELRIAH Score: A Simple Score for HCC Risk Stratification... | NCT04173520

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

NCT04173520

Sponsor

Egyptian Liver Hospital

Status

Completed

Last Update Posted

Nov 26, 2019Actual

Enrollment

2,326Actual

Phase

Not provided

Conditions

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015Actual

Primary Completion Date

Aug 2019Actual

Completion Date

Oct 30, 2019Actual

First Submitted Date

Nov 17, 2019

First Submission Date that Met QC Criteria

Nov 19, 2019

First Posted Date

Nov 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 22, 2019

Last Update Posted Date

Nov 26, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,326Actual

Name	Type	Description	Arm Group Labels	Other Names
DDA	Drug	Follow up after SVR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of HCC incidence after viral clearance		12-45 months after SVR

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

no history of previous HCC
SVR after DAAs treatment

Exclusion Criteria:

history of previous HCC

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

2326 CHC patients (638 patients with F3 and 1734 with F4 stage)

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000849	bis(p-chlorophenyl)acetic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided