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NCT Number: NCT06707129

Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged between 18 and 70 years at the time of liver biopsy;
  • Gender is not limited;
  • Hepatic perforation suggested that NASH complicated with fibrosis stage F2-4;
  • Signed written informed consent.

Exclusion criteria

  • Combined HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease Disease, drug-induced liver injury and other chronic liver diseases;
  • Women during pregnancy;
  • There are the following conditions before liver perforation: HCC or possible HCC (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); Patients with other malignant tumors; Recipients of liver transplantation;
  • Patients considered by the investigator to be unsuitable for this study.

Treatment and study plan

life-style

Other

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.

Primary outcomes

  1. Reversal of NASH liver fibrosis

    Time frame: 12 months

    Reversal of NASH liver fibrosis based on liver biopsy definition

Secondary outcomes

  1. Changes in LSM value

    Time frame: 12 months

    Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing

  2. Changes in liver fat content

    Time frame: 12 months

    Instantaneous liver elasticity detection of changes in liver fat content (CAP value)

  3. The dynamic changes of existing non-invasive evaluation models for fibrosis

    Time frame: 12 months

    The dynamic changes of existing non-invasive evaluation models for fibrosis include: APRI=AST(ULN)/PLT(10^9/L)×100

  4. The dynamic changes of existing non-invasive evaluation models for fibrosis

    Time frame: 12 months

    The dynamic changes of existing non-invasive evaluation models for fibrosis include:

    FIB-4: Age, AST, ALT, platelets

  5. The dynamic changes of existing non-invasive evaluation models for fibrosis

    Time frame: 12 months

    The dynamic changes of existing non-invasive evaluation models for fibrosis include:

    BARD：BMI ≥28, AST/ALT ≥0.8, diabetes

  6. The dynamic changes of existing non-invasive evaluation models for fibrosis

    Time frame: 12 months

    The dynamic changes of existing non-invasive evaluation models for fibrosis include:

    NAFLD Fibrosis Score

  7. The dynamic changes of existing non-invasive evaluation models for fibrosis

    Time frame: 12 months

    The dynamic changes of existing non-invasive evaluation models for fibrosis include:

    FAST

  8. Dynamic changes in metabolic indicators of NAFLD

    Time frame: 12 months

    Dynamic changes in metabolic indicators of NAFLD, including BMI;

  9. Dynamic changes in metabolic indicators of NAFLD

    Time frame: 12 months

    Dynamic changes in metabolic indicators of NAFLD, including body fat percentage;

  10. Dynamic changes in metabolic indicators of NAFLD

    Time frame: 12 months

    Dynamic changes in metabolic indicators of NAFLD, including blood pressure;

  11. Dynamic changes in metabolic indicators of NAFLD

    Time frame: 12 months

    Dynamic changes in metabolic indicators of NAFLD, including sugar;

  12. Dynamic changes in metabolic indicators of NAFLD

    Time frame: 12 months

    Dynamic changes in metabolic indicators of NAFLD, including glycated hemoglobin;

  13. Dynamic changes in metabolic indicators of NAFLD

    Time frame: 12 months

    Dynamic changes in metabolic indicators of NAFLD, including fasting insulin;

  14. Dynamic changes in metabolic indicators of NAFLD

    Time frame: 12 months

    Dynamic changes in metabolic indicators of NAFLD, including uric acid;

  15. Dynamic changes in metabolic indicators of NAFLD

    Time frame: 12 months

    Dynamic changes in metabolic indicators of NAFLD, including blood lipid series;

  16. The occurrence of cirrhosis

    Time frame: 12 months

    The occurrence of cirrhosis: that is, when the liver biopsy did not indicate cirrhosis at the time of enrollment, cirrhosis occurred during follow-up.

  17. The occurrence of liver outcome events

    Time frame: 12 months

    The occurrence of liver outcome events: decompensation of cirrhosis (ascites, rupture of esophageal and gastric varices) Blood, hepatic encephalopathy, hepatocellular carcinoma, liver related deaths/liver transplantation.

  18. Extrahepatic related events

    Time frame: 12 months

    Extrahepatic related events: cardiovascular and cerebrovascular events, extrahepatic malignant tumors, and newly developed metabolic diseases.

Study contacts

Contact information is provided by the study sponsor or research team.

Minghui Li

CONTACT

[email protected]

+8613693259096

Weihua Cao

CONTACT

[email protected]

+8618811333129

Sponsors and collaborators

Lead sponsor

Beijing Municipal Administration of Hospitals

Other Gov

Registry information

Official study title

Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Nov 27, 2024
Registry last updated
Nov 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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