Compensated Advanced Chronic Liver DiseaseNCT05100485
Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)
An observational study of Compensated Advanced Chronic Liver Disease, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
Trial summary
Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Compensated Advanced Chronic Liver Disease
- What is being tested?
- Esophagogasrtoduodendoscopy and Hepatic venous pressure gradient
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 1 Jan 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an international, multicenter cohort study initialed by Portal Hypertension Alliance in China (CHESS) and eligible patients will enroll from China, Japan, Southern Korea, Egypt, Singapore, and India.
Who may be able to join
- age above or equal to 18-year-old,
- fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
- age above or equal to 18-year-old,
- fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
Who cannot join
- prior hepatic decompensation,
- hepatocellular carcinoma,
- prior liver transplantation,
- portal vein thrombosis,
- antiplatelet or anticoagulation,
- without screening endoscopy within six months of transient elastography,
Show all 19Show fewer
- alcoholic cirrhosis with significant ongoing alcohol intake,
- presence of gastric varix,
- incomplete follow-up data.
- HVPG cohort.
- prior hepatic decompensation,
- hepatocellular carcinoma,
- prior liver transplantation,
- portal vein thrombosis,
- antiplatelet or anticoagulation,
- without screening endoscopy within six months of transient elastography,
- alcoholic cirrhosis with significant ongoing alcohol intake,
- presence of gastric varix,
- non-sinusoidal portal hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Novel Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)
Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation. The presence of CSPH (defined as hepatic venous pressure gradient [HVPG] ≥ 10 mmHg) is the strongest predictor of hepatic decompensation. However, HVPG measurement is invasive, operator dependent, and not widely available. According to the 2021 updated EASL Clinical Practice Guidelines, cACLD patients who did not meet the Baveno VI criteria but had any of the two variables (LSM > 20 kPa or PLT < 150 × 109/L) were suggested to perform screening endoscopy and HVPG measurement. However, the number of cACLD patients with unfavorable Baveno VI status is huge, no detailed risk stratifications existed at this timepoint. This study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.
Read the detailed description
Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation. The presence of CSPH (defined as hepatic venous pressure gradient [HVPG] ≥ 10 mmHg) is the strongest predictor of hepatic decompensation. However, HVPG measurement is invasive, operator dependent, and not widely available. According to the 2021 updated EASL Clinical Practice Guidelines, cACLD patients who did not meet the Baveno VI criteria but had any of the two variables (LSM > 20 kPa or PLT < 150 × 109/L) were suggested to perform screening endoscopy and HVPG measurement. However, the number of cACLD patients with unfavorable Baveno VI status is huge, no detailed risk stratifications existed at this timepoint. This international multicenter cohort study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.
- Being tested
- Esophagogasrtoduodendoscopy, Hepatic venous pressure gradient
- Keywords
- liver stiffness, platelets, portal hypertension, varices, compensated advanced chronic liver disease
- Medical subject headings
- Hypertension, Portal, Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsophagogasrtoduodendoscopyDiagnostic test
Esophagogasrtoduodendoscopy was used to detech the presence of varices.
Hepatic venous pressure gradientDiagnostic test
A method used to eveluate the portal pressure
| Study group | Role | What they receive |
|---|---|---|
| Training cohort | Training cohort was used to developement the new algorithm for predicting liver decompensation. Receives: Diagnostic Test: Esophagogasrtoduodendoscopy | |
| Validation cohort | Validation cohort was used to test the performance of the new algorithm in predicting liver decompensation. Receives: Diagnostic Test: Esophagogasrtoduodendoscopy | |
| HVPG cohort | HVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension. Receives: Diagnostic Test: Esophagogasrtoduodendoscopy; Diagnostic Test: Hepatic venous pressure gradient |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of a novel algorithm for predicting liver decompensation.
Aims to investigate the accuracy of the novel algorithm to stratify decompensation risk in patients with cACLD.
Measured: 3 years
Secondary outcomes (1)
The accuracy of the novel alogrithm for predicting clinically significant portal hypertension.
HVPG cohort was used to evaluate the accuracy of the novel alogrithm for predicting clinically significant portal hypertension.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start1 Jan 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Compensated Advanced Chronic Liver DiseaseStudies of the same condition, open and under way.
- 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu Province
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Second People's Hospital, The Third People's Hospital of Taiyuan, Ehime University Graduate School of Medicine, Korea University Ansan Hospital, Hyogo Medical University, Zagazig University, Institute of Liver and Biliary Sciences (ILBS), Changi General Hospital, Ruijin Hospital
- Responsible party
- Principal investigator, Xiaolong Qi, Hepatopancreatobiliary Surgery Institute of Gansu Province
- Investigators
- Xiaolong Qi, MD, Study chair, Lanzhou University First Affiliated HospitalQing Xie, MD, Principal investigator, Shanghai Jiao Tong university affiliated Ruijin HospitalJia Li, MD, Principal investigator, Tianjin Second People's HospitalYu Jun Wong, MD, Principal investigator, Changi General HospitalMasashi Hirooka, MD, Principal investigator, Ehime University Graduate School of MedicineHirayuki Enomoto, MD, Principal investigator, Hyogo Medical UniversityTae Hyung Kim, MD, Principal investigator, Korea UniversityAnsan HospitalAmr Shaaban Hanafy, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100485
- Sponsor's protocol ID
- CHESS2108
- Status last verified
- Apr 2023
- First submitted
- 20 Oct 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
PubMed 30215362de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
PubMed 26047908Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.
PubMed 30910320European Association for the Study of the Liver. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. J Hepatol. 2021 Sep;75(3):659-689. doi: 10.1016/j.jhep.2021.05.025. Epub 2021 Jun 21.
PubMed 34166721Albilllos A, Garcia-Tsao G. Classification of cirrhosis: the clinical use of HVPG measurements. Dis Markers. 2011;31(3):121-8. doi: 10.3233/DMA-2011-0834.
PubMed 22045397Ripoll C, Groszmann R, Garcia-Tsao G, Grace N, Burroughs A, Planas R, Escorsell A, Garcia-Pagan JC, Makuch R, Patch D, Matloff DS, Bosch J; Portal Hypertension Collaborative Group. Hepatic venous pressure gradient predicts clinical decompensation in patients with compensated cirrhosis. Gastroenterology. 2007 Aug;133(2):481-8. doi: 10.1053/j.gastro.2007.05.024. Epub 2007 May 21.
PubMed 17681169Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
PubMed 19724251Thabut D, Bureau C, Layese R, Bourcier V, Hammouche M, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Goria O, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle-Bladou C, Dao T, Pilette C, Silvain C, Christidis C, Capron D, Bernard-Chabert B, Hillaire S, Di Martino V, Sutton A, Audureau E, Roudot-Thoraval F, Nahon P; ANRS CO12 CirVir group. Validation of Baveno VI Criteria for Screening and Surveillance of Esophageal Varices in Patients With Compensated Cirrhosis and a Sustained Response to Antiviral Therapy. Gastroenterology. 2019 Mar;156(4):997-1009.e5. doi: 10.1053/j.gastro.2018.11.053. Epub 2019 Feb 13.
PubMed 30768988Abraldes JG, Bureau C, Stefanescu H, Augustin S, Ney M, Blasco H, Procopet B, Bosch J, Genesca J, Berzigotti A; Anticipate Investigators. Noninvasive tools and risk of clinically significant portal hypertension and varices in compensated cirrhosis: The "Anticipate" study. Hepatology. 2016 Dec;64(6):2173-2184. doi: 10.1002/hep.28824. Epub 2016 Oct 27.
PubMed 27639071Chen RC, Cai YJ, Wu JM, Wang XD, Song M, Wang YQ, Zheng MH, Chen YP, Lin Z, Shi KQ. Usefulness of albumin-bilirubin grade for evaluation of long-term prognosis for hepatitis B-related cirrhosis. J Viral Hepat. 2017 Mar;24(3):238-245. doi: 10.1111/jvh.12638. Epub 2016 Nov 14.
PubMed 27862671
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Algorithm to Stratify Clinical Decompensation Risk in Patients With Compensated Advanced Chronic Liver Disease (CHESS2108)
- ClinicalTrials.gov ID
- NCT05100485
- Acronym / sponsor ID
- CHESS2108
- Keywords
- liver stiffness, platelets, portal hypertension, varices, compensated advanced chronic liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Hepatopancreatobiliary Surgery Institute of Gansu ProvinceUniversity, hospital or other
- Collaborators
- Tianjin Second People's Hospital, The Third People's Hospital of Taiyuan, Ehime University Graduate School of Medicine, Korea University Ansan Hospital, Hyogo Medical University, Zagazig University, Institute of Liver and Biliary Sciences (ILBS), Changi General Hospital, Ruijin Hospital
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 29 Oct 2021 (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.
Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation. The presence of CSPH (defined as hepatic venous pressure gradient [HVPG] ≥ 10 mmHg) is the strongest predictor of hepatic decompensation. However, HVPG measurement is invasive, operator dependent, and not widely available. According to the 2021 updated EASL Clinical Practice Guidelines, cACLD patients who did not meet the Baveno VI criteria but had any of the two variables (LSM > 20 kPa or PLT < 150 × 109/L) were suggested to perform screening endoscopy and HVPG measurement. However, the number of cACLD patients with unfavorable Baveno VI status is huge, no detailed risk stratifications existed at this timepoint. This study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.
Detailed description
Compensated advanced chronic liver disease (cACLD) commonly indicates severe fibrosis and compensated cirrhosis at risk of developing clinically significant portal hypertension (CSPH) and hepatic decompensation. The presence of CSPH (defined as hepatic venous pressure gradient [HVPG] ≥ 10 mmHg) is the strongest predictor of hepatic decompensation. However, HVPG measurement is invasive, operator dependent, and not widely available. According to the 2021 updated EASL Clinical Practice Guidelines, cACLD patients who did not meet the Baveno VI criteria but had any of the two variables (LSM > 20 kPa or PLT < 150 × 109/L) were suggested to perform screening endoscopy and HVPG measurement. However, the number of cACLD patients with unfavorable Baveno VI status is huge, no detailed risk stratifications existed at this timepoint. This international multicenter cohort study intended to investigate a novel algorithm to stratify the decompensation risk in patients with cACLD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Training cohort | – | Diagnostic Test: EsophagogasrtoduodendoscopyTraining cohort was used to developement the new algorithm for predicting liver decompensation. |
| Validation cohort | – | Diagnostic Test: EsophagogasrtoduodendoscopyValidation cohort was used to test the performance of the new algorithm in predicting liver decompensation. |
| HVPG cohort | – | Diagnostic Test: Esophagogasrtoduodendoscopy, Diagnostic Test: Hepatic venous pressure gradientHVPG cohort, a cross-section cohort was used to study the diagnostic value of novel score for clinically significant portal hypertension. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an international, multicenter cohort study initialed by Portal Hypertension Alliance in China (CHESS) and eligible patients will enroll from China, Japan, Southern Korea, Egypt, Singapore, and India.
Key inclusion criteria (4 listed)
- age above or equal to 18-year-old,
- fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
- age above or equal to 18-year-old,
- fulfilled diagnosis of cACLD based on radiological, histological features of severe fibrosis or cirrhosis according to the Baveno VI consensus.
Key exclusion criteria (19 listed)
- prior hepatic decompensation,
- hepatocellular carcinoma,
- prior liver transplantation,
- portal vein thrombosis,
- antiplatelet or anticoagulation,
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 |
|---|---|---|
| EsophagogasrtoduodendoscopyEsophagogasrtoduodendoscopy was used to detech the presence of varices. | Diagnostic test | HVPG cohort, Training cohort, Validation cohort |
| Hepatic venous pressure gradientA method used to eveluate the portal pressure | Diagnostic test | HVPG cohort |
Primary outcome
Accuracy of a novel algorithm for predicting liver decompensation.
Time frame: 3 years
Aims to investigate the accuracy of the novel algorithm to stratify decompensation risk in patients with cACLD.
1 secondary outcome
The accuracy of the novel alogrithm for predicting clinically significant portal hypertension.
Time frame: 1 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Background: PubMed 30215362Qi X, Berzigotti A, Cardenas A, Sarin SK. Emerging non-invasive approaches for diagnosis and monitoring of portal hypertension. Lancet Gastroenterol Hepatol. 2018 Oct;3(10):708-719. doi: 10.1016/S2468-1253(18)30232-2.
- Background: PubMed 26047908de Franchis R; Baveno VI Faculty. Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension. J Hepatol. 2015 Sep;63(3):743-52. doi: 10.1016/j.jhep.2015.05.022. Epub 2015 Jun 3. No abstract available.
- Background: PubMed 30910320Villanueva C, Albillos A, Genesca J, Garcia-Pagan JC, Calleja JL, Aracil C, Banares R, Morillas RM, Poca M, Penas B, Augustin S, Abraldes JG, Alvarado E, Torres F, Bosch J. beta blockers to prevent decompensation of cirrhosis in patients with clinically significant portal hypertension (PREDESCI): a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2019 Apr 20;393(10181):1597-1608. doi: 10.1016/S0140-6736(18)31875-0. Epub 2019 Mar 22.
- Background: PubMed 34166721European Association for the Study of the Liver. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. J Hepatol. 2021 Sep;75(3):659-689. doi: 10.1016/j.jhep.2021.05.025. Epub 2021 Jun 21.
- Background: PubMed 22045397Albilllos A, Garcia-Tsao G. Classification of cirrhosis: the clinical use of HVPG measurements. Dis Markers. 2011;31(3):121-8. doi: 10.3233/DMA-2011-0834.
- Background: PubMed 17681169Ripoll C, Groszmann R, Garcia-Tsao G, Grace N, Burroughs A, Planas R, Escorsell A, Garcia-Pagan JC, Makuch R, Patch D, Matloff DS, Bosch J; Portal Hypertension Collaborative Group. Hepatic venous pressure gradient predicts clinical decompensation in patients with compensated cirrhosis. Gastroenterology. 2007 Aug;133(2):481-8. doi: 10.1053/j.gastro.2007.05.024. Epub 2007 May 21.
- Background: PubMed 19724251Bosch J, Abraldes JG, Berzigotti A, Garcia-Pagan JC. The clinical use of HVPG measurements in chronic liver disease. Nat Rev Gastroenterol Hepatol. 2009 Oct;6(10):573-82. doi: 10.1038/nrgastro.2009.149. Epub 2009 Sep 1.
- Background: PubMed 30768988Thabut D, Bureau C, Layese R, Bourcier V, Hammouche M, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Goria O, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle-Bladou C, Dao T, Pilette C, Silvain C, Christidis C, Capron D, Bernard-Chabert B, Hillaire S, Di Martino V, Sutton A, Audureau E, Roudot-Thoraval F, Nahon P; ANRS CO12 CirVir group. Validation of Baveno VI Criteria for Screening and Surveillance of Esophageal Varices in Patients With Compensated Cirrhosis and a Sustained Response to Antiviral Therapy. Gastroenterology. 2019 Mar;156(4):997-1009.e5. doi: 10.1053/j.gastro.2018.11.053. Epub 2019 Feb 13.
- Background: PubMed 27639071Abraldes JG, Bureau C, Stefanescu H, Augustin S, Ney M, Blasco H, Procopet B, Bosch J, Genesca J, Berzigotti A; Anticipate Investigators. Noninvasive tools and risk of clinically significant portal hypertension and varices in compensated cirrhosis: The "Anticipate" study. Hepatology. 2016 Dec;64(6):2173-2184. doi: 10.1002/hep.28824. Epub 2016 Oct 27.
- Background: PubMed 27862671Chen RC, Cai YJ, Wu JM, Wang XD, Song M, Wang YQ, Zheng MH, Chen YP, Lin Z, Shi KQ. Usefulness of albumin-bilirubin grade for evaluation of long-term prognosis for hepatitis B-related cirrhosis. J Viral Hepat. 2017 Mar;24(3):238-245. doi: 10.1111/jvh.12638. Epub 2016 Nov 14.
- Individual participant dataSharing planned: Undecided
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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.
Xiaolong Qi, MD study chair
Lanzhou University First Affiliated Hospital
Qing Xie, MD principal investigator
Shanghai Jiao Tong university affiliated Ruijin Hospital
Jia Li, MD principal investigator
Tianjin Second People's Hospital
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 Compensated Advanced Chronic Liver Disease, run by Hepatopancreatobiliary Surgery Institute of Gansu Province at 1 site in China.
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 4 inclusion and 19 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: finished, as of the sponsor's last update on 25 Apr 2023. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of a novel algorithm for predicting liver decompensation. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05100485, which also lists 10 linked publications.
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 25 Apr 2023; AzTrials last refreshed its copy on 30 Oct 2026.