Non-alcoholic Steatohepatitis Registry Platform Study

Last updated: October 9, 2025
Sponsor: AstraZeneca
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Scar Tissue

Treatment

N/A

Clinical Study ID

NCT06123858
D1843R00356
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

(1) 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:

  1. Liver biopsy was performed within 24 months before enrollment, and the pathologicaldiagnosis was NASH and the fibrosis stage was F2 or above;

  2. FibroScan-AST (FAST) score ≥ 0.30 within 24 months before enrollment;

  3. There are any of the following evidences of fatty liver

  4. Controlled attenuation parameter (CAP) > 285 dB/m within 24 months beforeenrollment;

  5. Liver ultrasonography showed fatty liver within 24 months before enrollment;

  6. 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

  7. Liver stiffness measurement (LSM) ≥ 7.5kPa by vibration-controlled transientelastography (VCTE) within 24 months before enrollment;

  8. The elasticity value of magnetic resonance elastography (MRE) examinationwithin 24 months before enrollment is ≥2.93kPa;

  9. If there is no liver biopsy and no liver elastography equipment is available inthe research center, FIB-4>1.3 (under 65 years old) or>2 (over 65 years old)within 3 months before enrollment.

Exclusion

Exclusion Criteria:

  1. History of liver transplantation;

  2. Patients with bleeding tendency or coagulation dysfunction (for example, bleedingtendency, such as hemophilia, suspected hemangioma or suspected hydatid infection);

  3. Exclude liver diseases caused by the following causes: alcoholic steatohepatitis,drug-induced, viral or autoimmune hepatitis, primary hemochromatosis, α1-antitrypsindeficiency, hepatolenticular degeneration, hypothyroidism, inflammatory boweldisease, Cushing's syndrome, celiac disease, β lipoprotein deficiency, lipoatrophicdiabetes mellitus, Mauriac syndrome, hypopituitarism, hypogonadism, polycysticovarian syndrome;

  4. Have a history of malignant tumors in the past 5 years, excluding malignant tumorsthat have been cured by the investigator's judgment;

  5. Pregnant or lactating women.

Study Design

Total Participants: 2500
Study Start date:
November 22, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing 100015
    China

    Active - Recruiting

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing 100070
    China

    Active - Recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 102218
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fuzhou, Fujian 350002
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian 350005
    China

    Active - Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Guangdong Provincial Traditional Chinese Medicine Hospital

    Guangzhou, Guangdong 510120
    China

    Active - Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510062
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan 450003
    China

    Active - Recruiting

  • People's Hospital of Zhengzhou

    Zhengzhou, Henan 450053
    China

    Active - Recruiting

  • The First Affiliated Hospital of Baotou Medical College

    Baotou, Inner Mongolia 014016
    China

    Site Not Available

  • The Sixth People's Hospital of Zhengzhou

    Nanjing, Jiangsu 450005
    China

    Site Not Available

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 220005
    China

    Active - Recruiting

  • Gaoxin Hospital of The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330012
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330019
    China

    Active - Recruiting

  • Binzhou Medical University Hospital

    Binzhou, Shandong 256603
    China

    Active - Recruiting

  • Qingdao Municipal Hospital

    Qingdao, Shandong 266011
    China

    Active - Recruiting

  • Qingdao Sixth People's Hospital

    Qingdao, Shandong 266033
    China

    Active - Recruiting

  • Shanghai East Hospital

    Shanghai, Shanghai 200120
    China

    Active - Recruiting

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Active - Recruiting

  • Xi'an Central Hospital

    Xi'an, Shanxi 710003
    China

    Active - Recruiting

  • Chengdu Fifth People's Hospital

    Chengdu, Sichuan 611130
    China

    Active - Recruiting

  • Second People's Hospital of Chengdu

    Chengdu, Sichuan 610017
    China

    Active - Recruiting

  • Tianjing Third Central Hospital

    Tianjing, Tianjing 300170
    China

    Site Not Available

  • The Xin Hua Hospital of Zhejiang Province

    Hangzhou, Zhejiang 310005
    China

    Active - Recruiting

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • Research Site

    Beijing,
    China

    Site Not Available

  • Research Site

    Beijing 1816670,
    China

    Active - Recruiting

  • Research Site

    Binzhou,
    China

    Site Not Available

  • Research Site

    Binzhou 1816336,
    China

    Site Not Available

  • Research Site

    Changchun,
    China

    Site Not Available

  • Research Site

    Changchun 2038180,
    China

    Active - Recruiting

  • Research Site

    Chengdu,
    China

    Site Not Available

  • Research Site

    Chengdu 1815286,
    China

    Site Not Available

  • Research Site

    Fuzhou,
    China

    Site Not Available

  • Research Site

    Fuzhou 1810821,
    China

    Active - Recruiting

  • Research Site

    Guangzhou,
    China

    Site Not Available

  • Research Site

    Guangzhou 1809858,
    China

    Active - Recruiting

  • Research Site

    Hangzhou,
    China

    Site Not Available

  • Research Site

    Hangzhou 1808926,
    China

    Active - Recruiting

  • Research Site

    Inner Mongolia,
    China

    Active - Recruiting

  • Research Site

    Nanchang,
    China

    Site Not Available

  • Research Site

    Nanchang 1800163,
    China

    Active - Recruiting

  • Research Site

    Qingdao,
    China

    Site Not Available

  • Research Site

    Qingdao 1797929,
    China

    Active - Recruiting

  • Research Site

    Shanghai,
    China

    Site Not Available

  • Research Site

    Shanghai 1796236,
    China

    Active - Recruiting

  • Research Site

    Shenyang,
    China

    Site Not Available

  • Research Site

    Shenyang 2034937,
    China

    Site Not Available

  • Research Site

    Taiyuan,
    China

    Site Not Available

  • Research Site

    Taiyuan 1793511,
    China

    Active - Recruiting

  • Research Site

    Tianjin,
    China

    Site Not Available

  • Research Site

    Tianjin 1792947,
    China

    Site Not Available

  • Research Site

    Wenzhou,
    China

    Site Not Available

  • Research Site

    Wenzhou 1791388,
    China

    Active - Recruiting

  • Research Site

    Xi'an,
    China

    Site Not Available

  • Research Site

    Xi'an 1790630,
    China

    Site Not Available

  • Research Site

    Xuzhou,
    China

    Site Not Available

  • Research Site

    Xuzhou 10630003,
    China

    Site Not Available

  • Research Site

    Zhengzhou,
    China

    Site Not Available

  • Research Site

    Zhengzhou 1784658,
    China

    Active - Recruiting

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