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

Sponsor

Mahidol University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05295914

Collaborator

(none)

600

Enrollment

Location

1.6

Anticipated Duration (Months)

365.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis B	Diagnostic Test: TREAT-B score

Detailed Description

According to WHO Global health sector strategy on viral hepatitis 2016- 2021, WHO aim to global eliminate HBV infection within 2030. Main strategies for achievement are effective prevention and treatment.

International and national guideline for HBV infection treatment recommend initiated antiviral in high HBV viral loads patients with significant liver inflammation and significant liver fibrosis. Thus, HBV viral load and liver elastography are required for indication assessment. In low-to-middle income country such as 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-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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

600 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Apr 10, 2022

Anticipated Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

May 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 TREAT-B score: ALT(alanine transferase), HBeAg REACH-B score: sex, ALT, HBV viral load, age WHO-simplified score: ALT, cirrhosis Other Names: WHO simplified score REACH-B score

Arm

Intervention/Treatment

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

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

Other Names:

WHO simplified score

REACH-B score

Outcome Measures

Primary Outcome Measures

Performance of TREAT-B score for eligible antiviral treatment [at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus)]
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
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)]
Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
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)]
Gold standard: Eligible antiviral treatment according to EASL criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Siriraj Hospital	Bangkok		Thailand	10700

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator: Watcharasak Chotiyaputta, Assoc prof, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Watcharasak Chotiyaputta, Associate professor, Faculty of Medicine, Siriraj Hospital, Mahidol University

ClinicalTrials.gov Identifier:

NCT05295914

Other Study ID Numbers:

Si 745/2021

First Posted:

Mar 25, 2022

Last Update Posted:

Apr 4, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Watcharasak Chotiyaputta, Associate professor, Faculty of Medicine, Siriraj Hospital, Mahidol University

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

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 4, 2022