An observational study in Chronic Hepatitis B, sponsored by Mahidol University. Status unknown at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-04.
Sponsored by Mahidol University · Observational
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's planned enrollment of 600 is above the median of 250 across 687 observational studies indexed under Hepatitis A.
Browse Hepatitis A studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Treatment naive chronic hepatitis B infection patients who visited at liver clinic and internal medicine clinic Siriraj hospital during January 2015-December 2021
Exclusion Criteria:
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
Also known as: WHO simplified score, REACH-B score
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
Time frame: 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
Time frame: 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
Time frame: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
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
Time frame: 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
Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
Time frame: 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 Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
Time frame: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
Plan to share: No
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This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Mahidol University