Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand

NCT05295914 | Unknown DMC

• 1 other identifier: Si 745/2021
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

International and national guideline for chronic hepatitis B (HBV) infection treatment recommend initiated antiviral in high HBV viral loads patients with significant liver inflammation and significant liver fibrosis. In Thailand, HBV viral loads and liver elastography are limited available in seconds to tertiary care hospital. Recently, many of simplified scoring system (TREAT-B score, WHO (World Health Organization)-simplified score and REACH-B score) were developed for assessment of antiviral initiation. This study aim to evaluate the performance of simplified score for chronic HBV treatment compare to Thailand and international standard guideline.

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B, TREAT-B, REACH-B, WHO criteria

Outcome Measures

Primary Outcomes (3)

• Performance of TREAT-B score for eligible antiviral treatment

  Gold standard: Eligible antiviral treatment according to EASL (European Association for the Study of the Liver) criteria Description: performance was define by sensitivity(%), specificity(%), PPV(positive predictive value)(%), NPV (negative predictive value)(%), positive LR(likelihood ratio), negative LR

  at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus)

• Performance of WHO simplified score for eligible antiviral treatment

  Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR

  at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)

• Performance of REACH-B score for eligible antiviral treatment

  Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR

  at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)

Secondary Outcomes (3)

• Performance of TREAT-B score for eligible antiviral treatment

  at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)

• Performance of WHO simplified score for eligible antiviral treatment

  at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)

• Performance of REACH-B score for eligible antiviral treatment

  at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)

Study Arms (1)

Patient with chronic hepatitis B infection

Patient with chronic hepatitis B infection visited at liver and internal medicine clinic, Siriraj hospital between January 2015-2020

Diagnostic Test: TREAT-B score

Interventions

TREAT-B score DIAGNOSTIC_TEST

TREAT-B score: ALT(alanine transferase), HBeAg REACH-B score: sex, ALT, HBV viral load, age WHO-simplified score: ALT, cirrhosis

Also known as: WHO simplified score, REACH-B score

Patient with chronic hepatitis B infection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Treatment naive chronic hepatitis B infection patients who visited at liver clinic and internal medicine clinic Siriraj hospital during January 2015-December 2021

You may qualify if:

• Treatment naive chronic hepatitis B infection patients who visited at liver clinic and internal medicine clinic Siriraj hospital during January 2015-December 2021
• Age \> 18 years

You may not qualify if:

• Treatment experience chronic hepatitis B infection patients
• HIV co-infection
• HCV (hepatitis C) co-infection
• concomitant HCC (hepatocellular carcinoma)
• Pregnancy
• Incomplete data

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Siriraj Hospital

Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Watcharasak Chotiyaputta, Assoc prof

  Mahidol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Watcharasak Chotiyaputta, Assoc Prof

CONTACT

6624197281; watcharasak.cho@mahidol.ac.th

Tawesak Tanwandee, Professor

CONTACT

6624197282; tawesak@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Faculty of Medicine, Siriraj Hospital

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 25, 2022
• Study Start: April 10, 2022
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: April 4, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)