Chronic Hepatitis BNCT05295914
Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand
An observational study of Chronic Hepatitis B, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- TREAT-B score
- How many people
- 600 participants
- Where
- 1 siteThailand
- Study dates
- 10 Apr 2022to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Treatment experience chronic hepatitis B infection patients
- HIV co-infection
- HCV (hepatitis C) co-infection
- concomitant HCC (hepatocellular carcinoma)
- Pregnancy
- Incomplete data
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Siriraj Hospital
Bangkok, 10700
Watcharasak Chotiyaputta, Asso Prof, 6624197281, watcharasak.cho@mahidol.ac.th
Tawesak Tanwandee, Prof, 6624197282, tawesak@gmail.com
About this study
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.
Read the 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- TREAT-B score
- Keywords
- chronic hepatitis B, TREAT-B, REACH-B, WHO criteria
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREAT-B scoreDiagnostic test
Also called WHO simplified score, REACH-B score
TREAT-B score: ALT(alanine transferase), HBeAg REACH-B score: sex, ALT, HBV viral load, age WHO-simplified score: ALT, cirrhosis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: TREAT-B score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Gold standard: Eligible antiviral treatment according to Thai guideline criteria Description: performance was define by sensitivity(%), specificity(%), PPV(%), NPV(%), positive LR, negative LR
Measured: 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
Measured: 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
Measured: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start10 Apr 2022 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Watcharasak Chotiyaputta, Mahidol University
- Investigators
- Watcharasak Chotiyaputta, Assoc prof, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05295914
- Sponsor's protocol ID
- Si 745/2021
- Status last verified
- Apr 2022
- First submitted
- 7 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Novel Simplified Score for Chronic Hepatitis B Treatment Eligibility in Thailand
- ClinicalTrials.gov ID
- NCT05295914
- Acronym / sponsor ID
- Si 745/2021
- Conditions
- Chronic Hepatitis B
- Keywords
- chronic hepatitis B, TREAT-B, REACH-B, WHO criteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with chronic hepatitis B infection | – | Diagnostic Test: TREAT-B scorePatient with chronic hepatitis B infection visited at liver and internal medicine clinic, Siriraj hospital between January 2015-2020 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Treatment experience chronic hepatitis B infection patients
- HIV co-infection
- HCV (hepatitis C) co-infection
- concomitant HCC (hepatocellular carcinoma)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREAT-B scoreAlso: WHO simplified score, REACH-B scoreTREAT-B score: ALT(alanine transferase), HBeAg REACH-B score: sex, ALT, HBV viral load, age WHO-simplified score: ALT, cirrhosis | Diagnostic test | Patient with chronic hepatitis B infection |
Primary outcome
Performance of TREAT-B score for eligible antiviral treatment
Time frame: 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
Time frame: 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
Time frame: 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
3 secondary outcomes
Performance of TREAT-B score for eligible antiviral treatment
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
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
Time frame: at 1st OPD visit through initiation of antivirus or 1 year (if not indication for antivirus)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Watcharasak Chotiyaputta, Assoc prof principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Watcharasak Chotiyaputta, Assoc Prof (6624197281, watcharasak.cho@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance of TREAT-B score for eligible antiviral treatment (time frame: at 1st OPD(out patient department) visit through initiation of antivirus or 1 year (if not indication for antivirus)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.