Liver InflammationNCT06802731
LivQ-box® Parameters in the Diagnosis of Liver Inflammation
An observational study of Liver Inflammation and Fatty Liver Disease, run by Wuxi Hisky Medical Technology Co Ltd at 1 site in China.
Trial summary
To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Inflammation, Fatty Liver Disease
- How many people
- 365 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases
Who may be able to join
- Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases;
- Age over 18 years old, gender not limited;
- Not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease);
- Perform iLivTouch examination within ± 14 days of liver pathology examination;
- No history of excessive alcohol consumption (converted to ethanol:<140g/week for males,<70g/week for females);
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Changgung Hospital (BTCH) affiliated to Tsinghua University
Beijing, Beijing Municipality, 102218
Lai Wei, 13601281862, weilai@pkuph.edu.cn
About this study
Official title: A Multicenter Study on the Application of LivQ-box® Parameters in the Diagnosis of Liver Inflammation in Patients with Non-alcoholic Fatty Liver Disease
To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.
Read the detailed description
This study is a multi-center study that retrospectively analyzed and prospectively included 240 NAFLD patients in total who met the inclusion criteria. The laboratory, iLivTouch, and liver biopsy results were collected to evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. In the end, cut-off values for different stages of inflammation were obtained.
- Conditions
- Liver Inflammation, Fatty Liver Disease
- Medical subject headings
- Hepatitis, Non-alcoholic Fatty Liver Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start1 Jan 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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 Liver InflammationStudies 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
- 365 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi Hisky Medical Technology Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06802731
- Sponsor's protocol ID
- HSKE-LI001
- Status last verified
- Jan 2025
- First submitted
- 13 Jan 2025
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Negro F. Natural history of NASH and HCC. Liver Int. 2020 Feb;40 Suppl 1:72-76. doi: 10.1111/liv.14362.
PubMed 32077608Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.
PubMed 32012320Man S, Deng Y, Ma Y, Fu J, Bao H, Yu C, Lv J, Liu H, Wang B, Li L. Prevalence of Liver Steatosis and Fibrosis in the General Population and Various High-Risk Populations: A Nationwide Study With 5.7 Million Adults in China. Gastroenterology. 2023 Oct;165(4):1025-1040. doi: 10.1053/j.gastro.2023.05.053. Epub 2023 Jun 26.
PubMed 37380136Oda K, Uto H, Mawatari S, Ido A. Clinical features of hepatocellular carcinoma associated with nonalcoholic fatty liver disease: a review of human studies. Clin J Gastroenterol. 2015 Feb;8(1):1-9. doi: 10.1007/s12328-014-0548-5. Epub 2015 Jan 10.
PubMed 25575848Rinella ME. Nonalcoholic fatty liver disease: a systematic review. JAMA. 2015 Jun 9;313(22):2263-73. doi: 10.1001/jama.2015.5370.
PubMed 26057287Alexander M, Loomis AK, van der Lei J, Duarte-Salles T, Prieto-Alhambra D, Ansell D, Pasqua A, Lapi F, Rijnbeek P, Mosseveld M, Waterworth DM, Kendrick S, Sattar N, Alazawi W. Risks and clinical predictors of cirrhosis and hepatocellular carcinoma diagnoses in adults with diagnosed NAFLD: real-world study of 18 million patients in four European cohorts. BMC Med. 2019 May 20;17(1):95. doi: 10.1186/s12916-019-1321-x.
PubMed 31104631Estes C, Anstee QM, Arias-Loste MT, Bantel H, Bellentani S, Caballeria J, Colombo M, Craxi A, Crespo J, Day CP, Eguchi Y, Geier A, Kondili LA, Kroy DC, Lazarus JV, Loomba R, Manns MP, Marchesini G, Nakajima A, Negro F, Petta S, Ratziu V, Romero-Gomez M, Sanyal A, Schattenberg JM, Tacke F, Tanaka J, Trautwein C, Wei L, Zeuzem S, Razavi H. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol. 2018 Oct;69(4):896-904. doi: 10.1016/j.jhep.2018.05.036. Epub 2018 Jun 8.
PubMed 29886156Wong VW, Wong GL, Tsang SW, Hui AY, Chan AW, Choi PC, Chim AM, Chu S, Chan FK, Sung JJ, Chan HL. Metabolic and histological features of non-alcoholic fatty liver disease patients with different serum alanine aminotransferase levels. Aliment Pharmacol Ther. 2009 Feb 15;29(4):387-96. doi: 10.1111/j.1365-2036.2008.03896.x. Epub 2008 Nov 17.
PubMed 19035982Harris R, Harman DJ, Card TR, Aithal GP, Guha IN. Prevalence of clinically significant liver disease within the general population, as defined by non-invasive markers of liver fibrosis: a systematic review. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):288-297. doi: 10.1016/S2468-1253(16)30205-9. Epub 2017 Feb 1.
PubMed 28404158Gao F, He Q, Li G, Huang OY, Tang LJ, Wang XD, Targher G, Byrne CD, Luo JW, Zheng MH. A novel quantitative ultrasound technique for identifying non-alcoholic steatohepatitis. Liver Int. 2022 Jan;42(1):80-91. doi: 10.1111/liv.15064. Epub 2021 Sep 30.
PubMed 34564946
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study on the Application of LivQ-box® Parameters in the Diagnosis of Liver Inflammation in Patients with Non-alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT06802731
- Acronym / sponsor ID
- HSKE-LI001
- Conditions
- Liver Inflammation, Fatty Liver Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 365 participants (estimated)
- Lead sponsor
- Wuxi Hisky Medical Technology Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tsinghua Changgeng Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 31 Jan 2025 (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.
To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.
Detailed description
This study is a multi-center study that retrospectively analyzed and prospectively included 240 NAFLD patients in total who met the inclusion criteria. The laboratory, iLivTouch, and liver biopsy results were collected to evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. In the end, cut-off values for different stages of inflammation were obtained.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases
Key inclusion criteria (5 listed)
- Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases;
- Age over 18 years old, gender not limited;
- Not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease);
- Perform iLivTouch examination within ± 14 days of liver pathology examination;
- No history of excessive alcohol consumption (converted to ethanol:<140g/week for males,<70g/week for females);
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Background: PubMed 32077608Negro F. Natural history of NASH and HCC. Liver Int. 2020 Feb;40 Suppl 1:72-76. doi: 10.1111/liv.14362.
- Background: PubMed 32012320Zhou J, Zhou F, Wang W, Zhang XJ, Ji YX, Zhang P, She ZG, Zhu L, Cai J, Li H. Epidemiological Features of NAFLD From 1999 to 2018 in China. Hepatology. 2020 May;71(5):1851-1864. doi: 10.1002/hep.31150.
- Background: PubMed 37380136Man S, Deng Y, Ma Y, Fu J, Bao H, Yu C, Lv J, Liu H, Wang B, Li L. Prevalence of Liver Steatosis and Fibrosis in the General Population and Various High-Risk Populations: A Nationwide Study With 5.7 Million Adults in China. Gastroenterology. 2023 Oct;165(4):1025-1040. doi: 10.1053/j.gastro.2023.05.053. Epub 2023 Jun 26.
- Background: PubMed 25575848Oda K, Uto H, Mawatari S, Ido A. Clinical features of hepatocellular carcinoma associated with nonalcoholic fatty liver disease: a review of human studies. Clin J Gastroenterol. 2015 Feb;8(1):1-9. doi: 10.1007/s12328-014-0548-5. Epub 2015 Jan 10.
- Background: PubMed 26057287Rinella ME. Nonalcoholic fatty liver disease: a systematic review. JAMA. 2015 Jun 9;313(22):2263-73. doi: 10.1001/jama.2015.5370.
- Background: PubMed 31104631Alexander M, Loomis AK, van der Lei J, Duarte-Salles T, Prieto-Alhambra D, Ansell D, Pasqua A, Lapi F, Rijnbeek P, Mosseveld M, Waterworth DM, Kendrick S, Sattar N, Alazawi W. Risks and clinical predictors of cirrhosis and hepatocellular carcinoma diagnoses in adults with diagnosed NAFLD: real-world study of 18 million patients in four European cohorts. BMC Med. 2019 May 20;17(1):95. doi: 10.1186/s12916-019-1321-x.
- Background: PubMed 29886156Estes C, Anstee QM, Arias-Loste MT, Bantel H, Bellentani S, Caballeria J, Colombo M, Craxi A, Crespo J, Day CP, Eguchi Y, Geier A, Kondili LA, Kroy DC, Lazarus JV, Loomba R, Manns MP, Marchesini G, Nakajima A, Negro F, Petta S, Ratziu V, Romero-Gomez M, Sanyal A, Schattenberg JM, Tacke F, Tanaka J, Trautwein C, Wei L, Zeuzem S, Razavi H. Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030. J Hepatol. 2018 Oct;69(4):896-904. doi: 10.1016/j.jhep.2018.05.036. Epub 2018 Jun 8.
- Background: PubMed 19035982Wong VW, Wong GL, Tsang SW, Hui AY, Chan AW, Choi PC, Chim AM, Chu S, Chan FK, Sung JJ, Chan HL. Metabolic and histological features of non-alcoholic fatty liver disease patients with different serum alanine aminotransferase levels. Aliment Pharmacol Ther. 2009 Feb 15;29(4):387-96. doi: 10.1111/j.1365-2036.2008.03896.x. Epub 2008 Nov 17.
- Background: PubMed 28404158Harris R, Harman DJ, Card TR, Aithal GP, Guha IN. Prevalence of clinically significant liver disease within the general population, as defined by non-invasive markers of liver fibrosis: a systematic review. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):288-297. doi: 10.1016/S2468-1253(16)30205-9. Epub 2017 Feb 1.
- Background: PubMed 34564946Gao F, He Q, Li G, Huang OY, Tang LJ, Wang XD, Targher G, Byrne CD, Luo JW, Zheng MH. A novel quantitative ultrasound technique for identifying non-alcoholic steatohepatitis. Liver Int. 2022 Jan;42(1):80-91. doi: 10.1111/liv.15064. Epub 2021 Sep 30.
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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.
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 Liver Inflammation and Fatty Liver Disease, run by Wuxi Hisky Medical Technology Co Ltd 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 5 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 31 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lai Wei (+86 13601281862, weilai@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the correlation and diagnostic performance of LivQ-box and cut-off values for different inflammation stages in NAFLD patients based on iLivTouch. (time frame: 12 months). 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 NCT06802731, 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 31 Jan 2025.