Chronic Hepatitis bNCT05786963
Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis
An observational study of Chronic Hepatitis b and Non-Alcoholic Fatty Liver Disease, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled. Patients' clinical characteristics, including alanine aminotransferase, aspartic aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, triglyceride and total… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis b, Non-Alcoholic Fatty Liver Disease
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 29 Dec 2022to Apr 2024
- 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: Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease.
Who may be able to join
- Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease;
- Age above 18 years;
- Signature of informed consent.
Who cannot join
- Patients with HCV and/or other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic liver disease or other chronic liver diseases;
- Patients with decompensated cirrhosis;
- Patients with serum total bilirubin level higher than 51 umol/L;
- Patients with liver malignant lesion, hemangiomas, giant liver cysts and other liver lesions;
- Patients with HIV infections;
- Patients after liver transplantation or TIPS;
- Pregnant women;
- Patients with Budd-Chiari syndrome, chronic congestive heart failure, constrictive pericarditis or other liver congestion lesions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yameng Sun
Beijing, Select A State Or Province, 100050
Shuyan Chen, Doctor, 8610-63138656, 13552962655@163.com
Yameng Sun, Doctor, 8610-63138656, sunyamenggo@163.com
About this study
Official title: Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis in Chronic Hepatitis B or NAFLD Patients
Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled. Patients' clinical characteristics, including alanine aminotransferase, aspartic aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, triglyceride and total cholesterol, hepatitis B surface antigen, steatosis, and liver stiffness measurement will be collected. The consistence of liver fibrosis and steatosis assessment between Hepatus and FibroScan will be evaluated in this study.
- Keywords
- Chronic Hepatitis b, Non-alcoholic Fatty Liver Disease, Liver fibrosis/cirrhosis, Steatosis
- Medical subject headings
- Hepatitis B, Chronic, Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Fibrosis, Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode.
Consistency of liver stiffness and steatosis between Hepatus and FibroScan.
Measured: 1 to 3 years
Secondary outcomes (3)
Consistency of liver stiffness and steatosis results between Hepatus in continuous measurement mode and FibroScan in single detection mode through the respective localization methods.
The localization method of Hepatus is the real-time two-dimensional image guiding system, which is manually location in FibroScan.
Measured: 1 to 3 years
Consistency of liver stiffness and steatosis results between Hepatus and FibroScan in single detection mode.
The localization methods include the respective localization methods in Hepatus and FibroScan, and manually locating.
Measured: 1 to 3 years
Comparison of measurement performance in Hepatus under continuous detection mode and in FibroScan through single detection mode.
Evaluation of measurement performance includes the rate of successful detection, time taken for validated detection, stability of liver stiffness measurement and controlled attenuation parameter.
Measured: 1 to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start29 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (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 Beijing Friendship HospitalThe 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
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hong You, Beijing Friendship Hospital
- Investigators
- Hong You, doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786963
- Sponsor's protocol ID
- YYYXYJ-2022-095
- Status last verified
- Mar 2023
- First submitted
- 27 Nov 2022
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis in Chronic Hepatitis B or NAFLD Patients
- ClinicalTrials.gov ID
- NCT05786963
- Acronym / sponsor ID
- YYYXYJ-2022-095
- Keywords
- Chronic Hepatitis b, Non-alcoholic Fatty Liver Disease, Liver fibrosis/cirrhosis, Steatosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 29 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 28 Mar 2023 (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.
Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled. Patients' clinical characteristics, including alanine aminotransferase, aspartic aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, triglyceride and total cholesterol, hepatitis B surface antigen, steatosis, and liver stiffness measurement will be collected. The consistence of liver fibrosis and steatosis assessment between Hepatus and FibroScan will be evaluated in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease.
Key inclusion criteria (3 listed)
- Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease;
- Age above 18 years;
- Signature of informed consent.
Key exclusion criteria (8 listed)
- Patients with HCV and/or other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic liver disease or other chronic liver diseases;
- Patients with decompensated cirrhosis;
- Patients with serum total bilirubin level higher than 51 umol/L;
- Patients with liver malignant lesion, hemangiomas, giant liver cysts and other liver lesions;
- Patients with HIV infections;
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
Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode.
Time frame: 1 to 3 years
Consistency of liver stiffness and steatosis between Hepatus and FibroScan.
3 secondary outcomes
Consistency of liver stiffness and steatosis results between Hepatus in continuous measurement mode and FibroScan in single detection mode through the respective localization methods.
Time frame: 1 to 3 years
Consistency of liver stiffness and steatosis results between Hepatus and FibroScan in single detection mode.
Time frame: 1 to 3 years
Comparison of measurement performance in Hepatus under continuous detection mode and in FibroScan through single detection mode.
Time frame: 1 to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
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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.
Hong You, doctor principal investigator
Beijing Friendship 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 Chronic Hepatitis b and Non-Alcoholic Fatty Liver Disease, run by Beijing Friendship Hospital 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 3 inclusion and 8 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 28 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong You, Doctor (86-010-63139019, youhong30@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode. (time frame: 1 to 3 years). 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 28 Mar 2023.