NCT06707129Recruiting
Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal
Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis
Source: ClinicalTrials.gov · Last updated 27 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 19 Nov 2024
- Start date
- 1 Aug 2024
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Beijing Municipal Administration of Hospitals
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06707129
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Aug 2024 to the primary completion date, 31 Aug 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- 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;
Other
- Women during pregnancy;
- Patients considered by the investigator to be unsuitable for this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Ditan Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.