Non-alcoholic Steatohepatitis Registry Platform Study

Status: Recruiting
Location: See all (17) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

∙ (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:

• 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;

⁃ 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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‣ 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.

Locations
Other Locations
China
Research Site
RECRUITING
Beijing
Research Site
NOT_YET_RECRUITING
Binzhou
Research Site
RECRUITING
Changchun
Research Site
RECRUITING
Fuzhou
Research Site
RECRUITING
Guangzhou
Research Site
RECRUITING
Hangzhou
Research Site
RECRUITING
Inner Mongolia
Research Site
RECRUITING
Nanchang
Research Site
RECRUITING
Qingdao
Research Site
NOT_YET_RECRUITING
Shanghai
Research Site
RECRUITING
Shanghai
Research Site
RECRUITING
Taiyuan
Research Site
RECRUITING
Wenzhou
Research Site
NOT_YET_RECRUITING
Xi'an
Research Site
RECRUITING
Xi'an
Research Site
NOT_YET_RECRUITING
Xuzhou
Research Site
RECRUITING
Zhengzhou
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2023-11-22
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 2500
Treatments
NASH with fibrosis
NASH patients with fibrosis receiving routine treatment
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov