Non-alcoholic Steatohepatitis Registry Platform Study

Launched by ASTRAZENECA · Nov 3, 2023

Keywords

ClinConnect Summary

The Non-alcoholic Steatohepatitis (NASH) Registry Platform Study is a research project focusing on understanding the characteristics, diagnosis, and treatment of Chinese patients with NASH who also have fibrosis, which is a scarring of the liver. The study is currently looking for participants aged 18 to 75 who have been diagnosed with NASH and show signs of liver fibrosis through various medical tests performed in the last two years. This study aims to gather valuable information that could help improve the management of this condition.

To be eligible for the trial, participants must have had a liver biopsy or certain imaging tests that confirm NASH and fibrosis. However, individuals with a history of liver transplantation, certain bleeding disorders, or other specific liver diseases won't be able to join. Participants in this study can expect to share their medical history and undergo tests that help researchers understand NASH better. Your involvement could play an important role in advancing knowledge about this condition and potentially improving treatment options for others in the future.

Gender

ALL

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
• • <!-- -->
• • 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.