Actively Recruiting

Age: 18Years - 70Years
All Genders
NCT06707129

Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Led by Beijing Municipal Administration of Hospitals · Updated on 2024-11-27

50

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.

CONDITIONS

Official Title

Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 70 years at the time of liver biopsy
  • No gender restriction
  • Diagnosed with NASH complicated with fibrosis stage F2 to F4 confirmed by liver biopsy
  • Signed written informed consent
Not Eligible

You will not qualify if you...

  • Presence of HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease, drug-induced liver injury, or other chronic liver diseases
  • Women who are pregnant
  • Before liver biopsy: presence of hepatocellular carcinoma or suspected malignant liver tumor based on imaging
  • Decompensated cirrhosis (including ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome)
  • Other malignant tumors
  • History of liver transplantation
  • Any condition deemed unsuitable by the investigator for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100015

Actively Recruiting

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Research Team

M

Minghui Li

CONTACT

W

Weihua Cao

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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