NASH With FibrosisNCT06123858

Non-alcoholic Steatohepatitis Registry Platform Study

An observational study of NASH With Fibrosis, run by AstraZeneca at 16 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This is a multi-center, prospective, observational registry platform study aimed at describing the clinical characteristics and diagnosis and treatment patterns of Chinese patients with nonalcoholic steatohepatitis (NASH) with fibrosis. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: NASH With Fibrosis
How many people: 1,122 participants
Where: 16 sitesChina
Study dates: 22 Nov 2023to 17 Oct 2025
How long will I take part?: 3 Years
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Subjects with NASH and fibrosis.

Who may be able to join

Subjects must be between 18 and 75 years old when signing the informed consent form, and must have the ability to sign the consent form independently; (2) NASH patients who meet one of the following conditions:
Liver biopsy was performed within 24 months before enrollment, and the pathological diagnosis was NASH and the fibrosis stage was F2 or above;
FibroScan-AST (FAST) score ≥ 0.30 within 24 months before enrollment;
There are any of the following evidences of fatty liver
Controlled attenuation parameter (CAP) > 285 dB/m within 24 months before enrollment;
Liver ultrasonography showed fatty liver within 24 months before enrollment;

Show all 11Show fewer

Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) examination within 24 months before enrollment showed liver fat fraction ≥ 5%; and any of the following evidence of liver fibrosis
Liver stiffness measurement (LSM) ≥ 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment;
The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is ≥2.93kPa;
If there is no liver biopsy and no liver elastography equipment is available in the research center, FIB-4>1.3 (under 65 years old) or>2 (over 65 years old) within 3 months before enrollment.

Who cannot join

History of liver transplantation;
Patients with bleeding tendency or coagulation dysfunction (for example, bleeding tendency, such as hemophilia, suspected hemangioma or suspected hydatid infection);
Exclude liver diseases caused by the following causes: alcoholic steatohepatitis, drug-induced, viral or autoimmune hepatitis, primary hemochromatosis, α1-antitrypsin deficiency, hepatolenticular degeneration, hypothyroidism, inflammatory bowel disease, Cushing's syndrome, celiac disease, β lipoprotein deficiency, lipoatrophic diabetes mellitus, Mauriac syndrome, hypopituitarism, hypogonadism, polycystic ovarian syndrome;
Have a history of malignant tumors in the past 5 years, excluding malignant tumors that have been cured by the investigator's judgment;
Pregnant or lactating women.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

China16 sites

Research Site
Beijing
Research Site
Changchun
Research Site
Chengdu
Research Site
Fuzhou
Research Site
Guangzhou
Research Site
Hangzhou
Research Site
Inner Mongolia
Research Site
Nanchang
Research Site
Qingdao
Research Site
Shanghai
Research Site
Shenyang
Research Site
Taiyuan
Research Site
Tianjin
Research Site
Wenzhou
Research Site
Xi'an
Research Site
Zhengzhou

Other trials in China

About this study

Read the detailed description

Non-alcoholic fatty liver disease (NAFLD) is a metabolic stress-induced liver injury closely related to insulin resistance and genetic susceptibility, and its disease spectrum includes non-alcoholic fatty liver (NAFL), non-alcoholic steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma (HCC). NASH is a severe form of NAFLD, defined as more than 5% hepatocellular steatosis combined with intralobular inflammation and hepatocellular ballooning degeneration. By conducting research on the NASH patient registry platform and collecting real-world data on the clinical characteristics and diagnosis and treatment patterns of NASH patients, including demographics, clinical characteristics, treatment, outcomes, healthcare utilization, lifestyle, and genotype, on the one hand, it can provide evidence of scientific value for clinical practice and formulate diagnosis and treatment guidelines, and on the other hand, it can promote the clinical development of NASH drugs in China.

This is a multi-center, prospective, observational registry platform study. Patient recruitment is tentatively scheduled from December 2023 to December 2024. NASH with fibrosis that meets the inclusion criteria but does not meet the exclusion criteria will be consecutively enrolled in the selected center. The estimated number of patients is 2,500, which will be adjusted according to the progress of research. Among these subjects, information on two genes, PNPLA3 and HSD17B13, will be collected from approximately 500 NASH patients with fibrosis stage F2 or higher.

Conditions: NASH With Fibrosis
Keywords: NASH；, NAFLD；, fibrosis.
Medical subject headings: Non-alcoholic Fatty Liver Disease, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06123858
Study group	Role	What they receive
NASH with fibrosis		NASH patients with fibrosis receiving routine treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

1.Patient demography
Gender (male, female) ，age (years)，time since pathological diagnosis of NASH (months)， proportion of comorbidities
Measured: Baseline
2.The proportion of 4 NASH treatment modalities at baseline and follow-up
NASH treatment modalities include：Drug treatment，Non-drug treatment，Combined treatment and No treatment received
Measured: up to 3-year follow-up
3.NASH Knowledge, Belief and Practice Questionnaire responses at baseline and follow-up
Describe the responses of patients to the NASH Knowledge, Belief and Practice Questionnaire at baseline and follow-up periods. The questionnaire includes NASH patients' knowledge, attitude, and behavior towards NASH disease, NASH-related medical service needs, expectations, satisfaction, and does not involve the evaluation of scores.
Measured: up to 3-year follow-up

Secondary outcomes (3)

1. The correlation between non-invasive diagnostic methods and pathological results of liver biopsy in NASH patients
Non-invasive diagnostic methods for NASH (serological or imaging indicators during baseline and follow-up periods, including FIB-4, APRI, NAFLD fibrosis score (NFS), BARD, fatty liver index (FLI), Hepatic steatosis index (HSI), VCTE, MRE, MRI-PDFF, FAST, etc.); Liver biopsy pathology: Liver biopsy pathology results during baseline and follow-up periods, including NASH pathological diagnosis, NAFLD activity score (NAS) and pathological fibrosis grade.
Measured: up to 3-year follow-up
2.The annual frequency of liver related visits
Liver-related visits include liver related outpatient visits, emergency department visits, and hospitalizations
Measured: up to 3-year follow-up
3.Total liver-related cost
Total liver-related cost includes total liver-related outpatient and hospitalization costs
Measured: up to 3-year follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Nov 202317 Oct 2025

First posted9 Nov 2023
Study start22 Nov 2023
Primary completion17 Oct 2025
Study completion17 Oct 2025

Why it stopped: Following a reassessment of the company's pipeline priorities, the sponsor has elected to discontinue this project prior to its planned completion

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for NASH With FibrosisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe 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: 1,122 participants (actual)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06123858
Sponsor's protocol ID: D1843R00356
Status last verified: Jul 2026
First submitted: 25 Oct 2023
Last updated: 29 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Publications

Lei M, Zou S, Liu Q, Li Y, Han J, Zhang Y, Pu C. Predicting Liver Stiffness Approximately 12 Months Ahead Using Serial Transient Elastography. Can J Gastroenterol Hepatol. 2026;2026(1):e1261185. doi: 10.1155/cjgh/1261185.
PubMed 42947406

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis

All NASH With Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-alcoholic Steatohepatitis Registry Platform Study
ClinicalTrials.gov ID: NCT06123858
Acronym / sponsor ID: D1843R00356
Conditions: NASH With Fibrosis
Keywords: NASH；, NAFLD；, fibrosis.
Study type: Observational
Recruitment status: TerminatedReason stopped: Following a reassessment of the company's pipeline priorities, the sponsor has elected to discontinue this project prior to its planned completion
Enrolment: 1,122 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 22 Nov 2023 (actual)
Primary completion: 17 Oct 2025 (actual)
Study completion: 17 Oct 2025 (actual)
First posted: 9 Nov 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 1

Arm	Type	Receives
NASH with fibrosis	–	–NASH patients with fibrosis receiving routine treatment

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects with NASH and fibrosis.

Key inclusion criteria (11 listed)

Subjects must be between 18 and 75 years old when signing the informed consent form, and must have the ability to sign the consent form independently; (2) NASH patients who meet one of the following conditions:
Liver biopsy was performed within 24 months before enrollment, and the pathological diagnosis was NASH and the fibrosis stage was F2 or above;
FibroScan-AST (FAST) score ≥ 0.30 within 24 months before enrollment;
There are any of the following evidences of fatty liver

Key exclusion criteria (5 listed)

History of liver transplantation;
Patients with bleeding tendency or coagulation dysfunction (for example, bleeding tendency, such as hemophilia, suspected hemangioma or suspected hydatid infection);
Exclude liver diseases caused by the following causes: alcoholic steatohepatitis, drug-induced, viral or autoimmune hepatitis, primary hemochromatosis, α1-antitrypsin deficiency, hepatolenticular degeneration, hypothyroidism, inflammatory bowel disease, Cushing's syndrome, celiac disease, β lipoprotein deficiency, lipoatrophic diabetes mellitus, Mauriac syndrome, hypopituitarism, hypogonadism, polycystic ovarian syndrome;
Have a history of malignant tumors in the past 5 years, excluding malignant tumors that have been cured by the investigator's judgment;
Pregnant or lactating women.

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

1.Patient demography
Time frame: Baseline
Gender (male, female) ，age (years)，time since pathological diagnosis of NASH (months)， proportion of comorbidities
2.The proportion of 4 NASH treatment modalities at baseline and follow-up
Time frame: up to 3-year follow-up
NASH treatment modalities include：Drug treatment，Non-drug treatment，Combined treatment and No treatment received
3.NASH Knowledge, Belief and Practice Questionnaire responses at baseline and follow-up
Time frame: up to 3-year follow-up
Describe the responses of patients to the NASH Knowledge, Belief and Practice Questionnaire at baseline and follow-up periods. The questionnaire includes NASH patients' knowledge, attitude, and behavior towards NASH disease, NASH-related medical service needs, expectations, satisfaction, and does not involve the evaluation of scores.

3 secondary outcomes

1. The correlation between non-invasive diagnostic methods and pathological results of liver biopsy in NASH patients
Time frame: up to 3-year follow-up
2.The annual frequency of liver related visits
Time frame: up to 3-year follow-up
3.Total liver-related cost
Time frame: up to 3-year follow-up

Results and safety

The study was stopped early (reason given: Following a reassessment of the company's pipeline priorities, the sponsor has elected to discontinue this project prior to its planned completion). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Derived from this study: PubMed 42947406Lei M, Zou S, Liu Q, Li Y, Han J, Zhang Y, Pu C. Predicting Liver Stiffness Approximately 12 Months Ahead Using Serial Transient Elastography. Can J Gastroenterol Hepatol. 2026;2026(1):e1261185. doi: 10.1155/cjgh/1261185.
CSR Synopsis RedactedLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Related trials for NASH With Fibrosis

RecruitingPhase 3
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
RecruitingPhase 2
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis

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.

Lai Wei principal investigator

Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of NASH With Fibrosis, run by AstraZeneca at 16 sites 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 11 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: stopped early, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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?

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?

1.Patient demography (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT06123858, which also lists 1 linked publication.

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 Jul 2026.