Registry platform for patients with NASH and fibrosis

Non-alcoholic Steatohepatitis Registry Platform Study

This study is collecting health information from Chinese patients with NASH and fibrosis to see how they are treated and how they respond, which could help improve future care and treatments.

Quick facts

• Study type: Observational
• Enrollment: 2500 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: AstraZeneca (industry)
• Locations: 18 sites (Beijing and 17 other locations)
• Trial ID: NCT06123858 on ClinicalTrials.gov

What this trial studies

This multi-center, prospective, observational registry platform study aims to collect and analyze clinical data from Chinese patients diagnosed with non-alcoholic steatohepatitis (NASH) with fibrosis. The study will gather real-world evidence on patient demographics, clinical characteristics, treatment patterns, and outcomes, as well as genetic information related to NASH. By doing so, it seeks to inform clinical practice and contribute to the development of treatment guidelines and new therapies for NASH in China. Patient recruitment is expected to take place from December 2023 to December 2024, with an estimated enrollment of 2,500 participants.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 who have been diagnosed with NASH and meet specific fibrosis criteria.

Not a fit: Patients with NASH who do not meet the inclusion criteria or have conditions that exclude them from participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients with NASH and fibrosis.

How similar studies have performed: Other studies focusing on NASH have shown promise in understanding the disease and developing treatment options, indicating that this approach is supported by prior research.

Eligibility criteria

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 pathological diagnosis 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

   1. Controlled attenuation parameter (CAP) \> 285 dB/m within 24 months before enrollment;
   2. Liver ultrasonography showed fatty liver within 24 months before enrollment;
   3. 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

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   1. Liver stiffness measurement (LSM) ≥ 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment;
   2. The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is ≥2.93kPa;
   3. 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.

Exclusion Criteria:

1. History of liver transplantation;
2. Patients with bleeding tendency or coagulation dysfunction (for example, bleeding tendency, 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-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;
4. Have a history of malignant tumors in the past 5 years, excluding malignant tumors that have been cured by the investigator's judgment;
5. Pregnant or lactating women.

Where this trial is running

Beijing and 17 other locations

• Research Site — Beijing, China (RECRUITING)
• Research Site — Binzhou, China (RECRUITING)
• Research Site — Changchun, China (RECRUITING)
• Research Site — Chengdu, China (RECRUITING)
• Research Site — Fuzhou, China (RECRUITING)
• Research Site — Guangzhou, China (RECRUITING)
• Research Site — Hangzhou, China (RECRUITING)
• Research Site — Inner Mongolia, China (RECRUITING)
• Research Site — Nanchang, China (RECRUITING)
• Research Site — Qingdao, China (RECRUITING)
• Research Site — Shanghai, China (RECRUITING)
• Research Site — Shenyang, China (RECRUITING)
• Research Site — Taiyuan, China (RECRUITING)
• Research Site — Tianjin, China (RECRUITING)
• Research Site — Wenzhou, China (RECRUITING)
• Research Site — Xi'an, China (RECRUITING)
• Research Site — Xuzhou, China (RECRUITING)
• Research Site — Zhengzhou, China (RECRUITING)

Study contacts

• Principal investigator: Lai Wei — Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University
• Study coordinator: AstraZeneca Clinical Study Information Center

Conditions: NASH With Fibrosis, NASH；, NAFLD；, fibrosis.