NASHNCT06364462
Precise Evaluation Criteria for Histological Regression of NASH Fibrosis
An observational study of NASH and Liver Fibrosis, run by Beijing Friendship Hospital.
Trial summary
It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- NASH, Liver Fibrosis
- What is being tested?
- lifestyle intervention
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 1 Apr 2027
- How long will I take part?
- 3 Years
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NASH patients with fibrosis stage F2-4 diagnosed with liver biopsy
Who may be able to join
- 18-70 years of age.
- Liver biopsy-proven NASH fibrosis with stage F2-4.
- Signature of written informed consent.
Who cannot join
- Patients with other liver diseases, including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, genetic metabolic liver disease, drug-induced liver diseases, and infected with HIV.
- Pregnant women.
- Patients have the following conditions before liver biopsy:
- Hepatocellular carcinoma or suspected liver cancer; Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; Other malignancy; Undergone liver transplantation surgery;
- Patients with any other reasons not suitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis
It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.
- Conditions
- NASH, Liver Fibrosis
- Being tested
- lifestyle intervention
- Keywords
- NASH, Liver fibrosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle interventionOther
Dietary recommendations should consider energy restriction and exclusion of MAFLD-mediating components (processed food, food and beverages high in added fructose). A Mediterranean type diet is advisable. Both aerobic exercise and resistance training effectively reduce liver fat and should be tailored based on patient preferences to ensure long-term adherence.
| Study group | Role | What they receive |
|---|---|---|
| Observational group of NASH-related liver fibrosis | Not described Receives: Other: lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of NASH fibrosis
Regression of NASH fibrosis based on liver biopsy
Measured: 1-3 years
Secondary outcomes (14)
Dynamic changes of liver stiffness measurements (LSM)
Dynamic changes of liver stiffness measurements (LSM)
Measured: 3 years
Dynamic changes of Controlled Attenuation Parameter (CAP)
Dynamic changes of CAP, higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of Magnetic Resonance Elastography (MRE)
Dynamic changes of MRE, higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
Dynamic changes of MRI-PDFF, higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of non-invasive liver fibrosis models
Dynamic changes of Aspartate Aminotransferase to Platelet Ratio Index (APRI), , higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of non-invasive liver fibrosis models
Dynamic changes of Fibrosis-4 Index (FIB-4), higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of non-invasive liver fibrosis models
Dynamic changes of BARD (BMI, AST/ALT Ratio, Diabetes), higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of non-invasive liver fibrosis models
Dynamic changes of NAFLD Fibrosis Score (NFS), higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of non-invasive liver fibrosis models
Dynamic changes of FibroScan-aspartate aminotransferase score (FAST), higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of metabolic markers
Dynamic changes of Body Mass Index (BMI), higher scores mean a worse outcome.
Measured: 3 years
Dynamic changes of metabolic markers
Dynamic changes of fasting glucose
Measured: 3 years
Dynamic changes of metabolic markers
Dynamic changes of serum lipid level
Measured: 3 years
Incidence of liver-related events
Incidence of ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatocellular carcinoma, liver-related death/liver transplantation
Measured: 3 years
Incidence of extrahepatic related events
Incidence of cardiovascular and cerebrovascular events, extrahepatic malignancies, metabolic diseases
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start15 Jun 2024 (estimated)
- Primary completion9 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NASHStudies 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
- Prospective
- Enrolment
- 220 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jidong Jia, Beijing Friendship Hospital
- Investigators
- Jidong Jia, Professor, Principal investigator, Beijing Friendship HospitalJingmin Zhao, Professor, Principal investigator, Beijing 302 HospitalJing Zhang, Principal investigator, Beijing You-an Hospital, Capital Medical UniversityMinghui Li, Principal investigator, Beijing Ditan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364462
- Sponsor's protocol ID
- ZLRK202301
- Status last verified
- May 2024
- First submitted
- 12 Mar 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of Precise Evaluation Criteria for Histological Regression of NASH-related Liver Fibrosis
- ClinicalTrials.gov ID
- NCT06364462
- Acronym / sponsor ID
- ZLRK202301
- Conditions
- NASH, Liver Fibrosis
- Keywords
- NASH, Liver fibrosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 15 Apr 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.
It is an observational study of NASH patients with a calculated sample size of 220. Liver biopsy-proven NASH fibrosis with stage F2-F4 will be recruited in this study. A second biopsy will be performed after clinical trials or 1-3 years of lifestyle intervention. Patients will be followed up at baseline and every six months with h-CRP, liver function tests, fasting blood glucose, fasting insulin, ferritin, liver ultrasonography, and liver stiffness measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational group of NASH-related liver fibrosis | – | Other: lifestyle intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NASH patients with fibrosis stage F2-4 diagnosed with liver biopsy
Key inclusion criteria (3 listed)
- 18-70 years of age.
- Liver biopsy-proven NASH fibrosis with stage F2-4.
- Signature of written informed consent.
Key exclusion criteria (5 listed)
- Patients with other liver diseases, including viral hepatitis, alcoholic liver diseases, autoimmune liver diseases, genetic metabolic liver disease, drug-induced liver diseases, and infected with HIV.
- Pregnant women.
- Patients have the following conditions before liver biopsy:
- Hepatocellular carcinoma or suspected liver cancer; Decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal variceal bleeding, hepatorenal syndrome; Other malignancy; Undergone liver transplantation surgery;
- Patients with any other reasons not suitable for the 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 |
|---|---|---|
| lifestyle interventionDietary recommendations should consider energy restriction and exclusion of MAFLD-mediating components (processed food, food and beverages high in added fructose). A Mediterranean type diet is advisable. Both aerobic exercise and resistance training effectively reduce liver fat and should be tailored based on patient preferences to ensure long-term adherence. | Other | Observational group of NASH-related liver fibrosis |
Primary outcome
Regression of NASH fibrosis
Time frame: 1-3 years
Regression of NASH fibrosis based on liver biopsy
14 secondary outcomes
Dynamic changes of liver stiffness measurements (LSM)
Time frame: 3 years
Dynamic changes of Controlled Attenuation Parameter (CAP)
Time frame: 3 years
Dynamic changes of Magnetic Resonance Elastography (MRE)
Time frame: 3 years
Dynamic changes of Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)
Time frame: 3 years
Dynamic changes of non-invasive liver fibrosis models
Time frame: 3 years
Dynamic changes of non-invasive liver fibrosis models
Time frame: 3 years
Dynamic changes of non-invasive liver fibrosis models
Time frame: 3 years
Dynamic changes of non-invasive liver fibrosis models
Time frame: 3 years
Dynamic changes of non-invasive liver fibrosis models
Time frame: 3 years
Dynamic changes of metabolic markers
Time frame: 3 years
Dynamic changes of metabolic markers
Time frame: 3 years
Dynamic changes of metabolic markers
Time frame: 3 years
Incidence of liver-related events
Time frame: 3 years
Incidence of extrahepatic related events
Time frame: 3 years
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 29 May 2024.
- 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.
Jidong Jia, Professor principal investigator
Beijing Friendship Hospital
Jingmin Zhao, Professor principal investigator
Beijing 302 Hospital
Jing Zhang principal investigator
Beijing You-an Hospital, Capital Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of NASH and Liver Fibrosis, run by Beijing Friendship Hospital.
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 5 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: opening soon, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yameng Sun, M.D. (86-010-63138656, sunyamenggo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regression of NASH fibrosis (time frame: 1-3 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 29 May 2024.