NCT06707129

Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Beijing Municipal Administration of Hospitals · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Confirmed NAFLD patients were enrolled, and those with NASH and fibrosis F2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. A NASH "fibrosis reversal" pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
OTHER	life-style	The patients were given health education and lifestyle intervention guidance, followed by lifestyle adjustment for at least 1 year and no more than 3 years, and a second liver biopsy was performed to evaluate liver histological changes.

Timeline

• Start date: 2024-08-01
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2024-11-27
• Last updated: 2024-11-27

Locations

1 site across 1 country: China