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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05295914
• Other study ID #: Si 745/2021
• Status: Not yet recruiting
• Start date: April 10, 2022
• Est. completion date: May 30, 2022

Study information

• Verified date: April 2022
• Source: Mahidol University
• Contact: Watcharasak Chotiyaputta, Assoc Prof
• Phone: 6624197281
• Email: watcharasak.cho[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
Thailand	Siriraj Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	Performance of TREAT-B score for eligible antiviral treatment	Gold standard: Eligible antiviral treatment according to Thai guideline 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	Performance of WHO simplified score for eligible antiviral treatment	Gold standard: Eligible antiviral treatment according to Thai guideline 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	Performance of REACH-B score for eligible antiviral treatment	Gold standard: Eligible antiviral treatment according to Thai guideline 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)