Non-alcoholic steatohepatitis registry platform study

Study identifier:D1843R00356

ClinicalTrials.gov identifier:NCT06123858

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

Non-alcoholic steatohepatitis registry platform study

Medical condition

NASH with fibrosis

Phase

N/A

Healthy volunteers

Study drug

Sex

All

Estimated Enrollment

2500

Study type

Observational

Age

18 Years - 75 Years

Date

Study Start Date: 22 Nov 2023

Estimated Primary Completion Date: 31 Dec 2026

Estimated Study Completion Date: 31 Dec 2026

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: -
Masking: -
Primary Purpose: -

Verification:

Verified 01 Apr 2024 by AstraZeneca

Collaborators

Inclusion and exclusion 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
a) Controlled attenuation parameter (CAP) > 285 dB/m within 24 months before enrollment;
b) Liver ultrasonography showed fatty liver within 24 months before enrollment;
c) 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
a) Liver stiffness measurement (LSM) ≥ 7.5kPa by vibration-controlled transient elastography (VCTE) within 24 months before enrollment;
b) The elasticity value of magnetic resonance elastography (MRE) examination within 24 months before enrollment is ≥2.93kPa;
c) 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.

Sort by status

No locations available

Arms	Assigned Interventions
NASH with fibrosis NASH patients with fibrosis receiving routine treatment	-

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Lai Wei

Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University

Non-alcoholic steatohepatitis registry platform study

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Estimated Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Contacts

Contact

Investigators

Principal Investigator