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

1. april 2022 oppdatert av: Watcharasak Chotiyaputta, Mahidol University

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Forventet)

600

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

  • Navn: Tawesak Tanwandee, Professor
  • Telefonnummer: 6624197282
  • E-post: tawesak@gmail.com

Studiesteder

  • Thailand
      • Bangkok, Thailand, 10700
        • Siriraj Hospital
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Watcharasak Chotiyaputta, Asso Prof
        • Underetterforsker:
          • Tawesak Tanwandee, Prof
        • Underetterforsker:
          • Tanawat Geeratragool, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

N/A

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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
Diagnostisk 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
Andre navn:
  • WHO simplified score
  • REACH-B score

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Performance of TREAT-B score for eligible antiviral treatment
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Performance of TREAT-B score for eligible antiviral treatment
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mahidol University

Etterforskere

  • Hovedetterforsker: Watcharasak Chotiyaputta, Assoc prof, Mahidol university

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Forventet)

10. april 2022

Primær fullføring (Forventet)

30. mai 2022

Studiet fullført (Forventet)

30. mai 2022

Datoer for studieregistrering

Først innsendt

7. mars 2022

Først innsendt som oppfylte QC-kriteriene

15. mars 2022

Først lagt ut (Faktiske)

25. mars 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. april 2022

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. april 2022

Sist bekreftet

1. april 2022

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Si 745/2021

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Nei

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Nei

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