Non-alcoholic Fatty Liver DiseaseNCT06707129
Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal
An observational study of Non-alcoholic Fatty Liver Disease, run by Beijing Municipal Administration of Hospitals at 1 site in China.
Trial summary
Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- life-style
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Aug 2027
- How long will I take part?
- 12 Months
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with NAFLD were enrolled, and patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy were screened
Who may be able to join
- Aged between 18 and 70 years at the time of liver biopsy;
- Gender is not limited;
- Hepatic perforation suggested that NASH complicated with fibrosis stage F2-4;
- Signed written informed consent.
Who cannot join
- Combined HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease Disease, drug-induced liver injury and other chronic liver diseases;
- Women during pregnancy;
- There are the following conditions before liver perforation: HCC or possible HCC (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); Patients with other malignant tumors; Recipients of liver transplantation;
- Patients considered by the investigator to be unsuitable for this study.
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 Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Minghui Li, Dr, +8613693259096, wuhm2000@sina.com
Weihua Cao, Dr, +8618811333139, weihuacaohappy@163.com
About this study
Official title: Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis
Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.
Read the detailed description
Confirmed NAFLD patients were enrolled, and those with NASH and fibrosis F2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. A NASH "fibrosis reversal" pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- life-style
- Keywords
- non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, liver biopsy, Fibrosis reversal, histopathology
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
life-styleOther
The patients were given health education and lifestyle intervention guidance, followed by lifestyle adjustment for at least 1 year and no more than 3 years, and a second liver biopsy was performed to evaluate liver histological changes.
| Study group | Role | What they receive |
|---|---|---|
| Case group | After successful patient screening and enrollment, visits will be conducted every 6 months to collect the following information: Physical examination, accompanying diseases, hematology: blood routine, coagulation function, serology, imaging, body fat measurement, liver puncture information (if applicable). Lifestyle questionnaire: Dietary characteristics, sleep/wake time, daily sitting time, exercise duration, exercise mode. Health education and lifestyle intervention guidance should be provided to patients based on exercise mode. When adjusting lifestyle for at least 1 year and no more than 3 years, a second liver biopsy should be performed to evaluate liver histological changes. Receives: Other: life-style |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversal of NASH liver fibrosis
Reversal of NASH liver fibrosis based on liver biopsy definition
Measured: 12 months
Secondary outcomes (18)
Changes in LSM value
Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing
Measured: 12 months
Changes in liver fat content
Instantaneous liver elasticity detection of changes in liver fat content (CAP value)
Measured: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
The dynamic changes of existing non-invasive evaluation models for fibrosis include: APRI=AST(ULN)/PLT(10^9/L)×100
Measured: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
The dynamic changes of existing non-invasive evaluation models for fibrosis include:
FIB-4: Age, AST, ALT, platelets
Measured: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
The dynamic changes of existing non-invasive evaluation models for fibrosis include:
BARD：BMI ≥28, AST/ALT ≥0.8, diabetes
Measured: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
The dynamic changes of existing non-invasive evaluation models for fibrosis include:
NAFLD Fibrosis Score
Measured: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
The dynamic changes of existing non-invasive evaluation models for fibrosis include:
FAST
Measured: 12 months
Dynamic changes in metabolic indicators of NAFLD
Dynamic changes in metabolic indicators of NAFLD, including BMI;
Measured: 12 months
Dynamic changes in metabolic indicators of NAFLD
Dynamic changes in metabolic indicators of NAFLD, including body fat percentage;
Measured: 12 months
Dynamic changes in metabolic indicators of NAFLD
Dynamic changes in metabolic indicators of NAFLD, including blood pressure;
Measured: 12 months
Dynamic changes in metabolic indicators of NAFLD
Dynamic changes in metabolic indicators of NAFLD, including sugar;
Measured: 12 months
Dynamic changes in metabolic indicators of NAFLD
Dynamic changes in metabolic indicators of NAFLD, including glycated hemoglobin;
Measured: 12 months
Dynamic changes in metabolic indicators of NAFLD
Dynamic changes in metabolic indicators of NAFLD, including fasting insulin;
Measured: 12 months
Dynamic changes in metabolic indicators of NAFLD
Dynamic changes in metabolic indicators of NAFLD, including uric acid;
Measured: 12 months
Dynamic changes in metabolic indicators of NAFLD
Dynamic changes in metabolic indicators of NAFLD, including blood lipid series;
Measured: 12 months
The occurrence of cirrhosis
The occurrence of cirrhosis: that is, when the liver biopsy did not indicate cirrhosis at the time of enrollment, cirrhosis occurred during follow-up.
Measured: 12 months
The occurrence of liver outcome events
The occurrence of liver outcome events: decompensation of cirrhosis (ascites, rupture of esophageal and gastric varices) Blood, hepatic encephalopathy, hepatocellular carcinoma, liver related deaths/liver transplantation.
Measured: 12 months
Extrahepatic related events
Extrahepatic related events: cardiovascular and cerebrovascular events, extrahepatic malignant tumors, and newly developed metabolic diseases.
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 posted27 Nov 2024
- Study start1 Aug 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Minghui Li, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707129
- Sponsor's protocol ID
- ZLRK202301
- Status last verified
- Nov 2024
- First submitted
- 19 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis
- ClinicalTrials.gov ID
- NCT06707129
- Acronym / sponsor ID
- ZLRK202301
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, liver biopsy, Fibrosis reversal, histopathology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing Municipal Administration of HospitalsOther government
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Nov 2024 (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.
Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.
Detailed description
Confirmed NAFLD patients were enrolled, and those with NASH and fibrosis F2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. A NASH "fibrosis reversal" pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Case group | – | Other: life-styleAfter successful patient screening and enrollment, visits will be conducted every 6 months to collect the following information: Physical examination, accompanying diseases, hematology: blood routine, coagulation function, serology, imaging, body fat measurement, liver puncture information (if applicable). Lifestyle questionnaire: Dietary characteristics, sleep/wake time, daily sitting time, exercise duration, exercise mode. Health education and lifestyle intervention guidance should be provided to patients based on exercise mode. When adjusting lifestyle for at least 1 year and no more than 3 years, a second liver biopsy should be performed to evaluate liver histological changes. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with NAFLD were enrolled, and patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy were screened
Key inclusion criteria (4 listed)
- Aged between 18 and 70 years at the time of liver biopsy;
- Gender is not limited;
- Hepatic perforation suggested that NASH complicated with fibrosis stage F2-4;
- Signed written informed consent.
Key exclusion criteria (4 listed)
- Combined HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease Disease, drug-induced liver injury and other chronic liver diseases;
- Women during pregnancy;
- There are the following conditions before liver perforation: HCC or possible HCC (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); Patients with other malignant tumors; Recipients of liver transplantation;
- Patients considered by the investigator to be unsuitable for this study.
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 |
|---|---|---|
| life-styleThe patients were given health education and lifestyle intervention guidance, followed by lifestyle adjustment for at least 1 year and no more than 3 years, and a second liver biopsy was performed to evaluate liver histological changes. | Other | Case group |
Primary outcome
Reversal of NASH liver fibrosis
Time frame: 12 months
Reversal of NASH liver fibrosis based on liver biopsy definition
18 secondary outcomes
Changes in LSM value
Time frame: 12 months
Changes in liver fat content
Time frame: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time frame: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time frame: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time frame: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time frame: 12 months
The dynamic changes of existing non-invasive evaluation models for fibrosis
Time frame: 12 months
Dynamic changes in metabolic indicators of NAFLD
Time frame: 12 months
Dynamic changes in metabolic indicators of NAFLD
Time frame: 12 months
Dynamic changes in metabolic indicators of NAFLD
Time frame: 12 months
Dynamic changes in metabolic indicators of NAFLD
Time frame: 12 months
Dynamic changes in metabolic indicators of NAFLD
Time frame: 12 months
Dynamic changes in metabolic indicators of NAFLD
Time frame: 12 months
Dynamic changes in metabolic indicators of NAFLD
Time frame: 12 months
Dynamic changes in metabolic indicators of NAFLD
Time frame: 12 months
The occurrence of cirrhosis
Time frame: 12 months
The occurrence of liver outcome events
Time frame: 12 months
Extrahepatic related events
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 27 Nov 2024.
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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 Non-alcoholic Fatty Liver Disease, run by Beijing Municipal Administration of Hospitals 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 4 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 27 Nov 2024. 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 Minghui Li (+8613693259096, wuhm2000@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversal of NASH liver fibrosis (time frame: 12 months). 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 27 Nov 2024.