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A Clinical Study Evaluating the Association between NASH/Fibrosis and Metabolic

A Clinical Study Evaluating the Association between NASH/Fibrosis and Metabolic

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OOC-16007902
Enrollment
Unknown
Registered
2016-02-05
Start date
2016-05-23
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nonalcoholic fatty liver disease

Interventions

NA:NA

Sponsors

Shanghai Xinhua Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18-65 years 2. Patients who had got pathological biopsy confirming NAFLD results within 6 months before enrolment 3. NAFLD biopsy sample could be collected for rereading 4. Willing to follow protocol requirement to identify if patients have MS according to IDF definition 5. Able and willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. Chronic viral hepatitis, alcoholic liver disease (ALD), autoimmune liver disease, toxic liver damages and drug-induced liver injury; 2. End-stage liver disease such as cirrhosis and hepatocellular carcinoma (HCC); 3. Hepatolenticular degeneration (Wilson's disease) and other metabolic, genetic liver disease; 4. Pregnancy or breast feeding; 5. Unable to participate in the study due to any reasons.

Design outcomes

Primary

MeasureTime frame
Percentage of NASH/ fibrosis in NAFLD patients confirmed by liver biopsy with or without MS;

Secondary

MeasureTime frame
Percentage of NAFL in NAFLD patients confirmed by liver biopsy with or without MS;Percentage of NAFL and NASH/ fibrosis in NAFLD patients confirmed by liver biopsy in different severity levels diagnosed by transient elastography;Percentage of NAFL and NASH/ fibrosis in NAFLD patients confirmed by liver biopsy in different severity levels diagnosed by ultrasonography (mild, moderate and severe);Percentage of NAFL and NASH/ fibrosis in NAFLD confirmed by liver biopsy patients with or without aminotransferase elevation;Percentage of NAFL and NASH/ fibrosis in NAFLD confirmed by liver biopsy patients with different CVD risk (low, intermediate and high). CVD risk will be estimated using the Framingham general CVD risk score (2008) algorithm;Percentage of different kind of symptoms in different pathological stage of NAFLD;CK-18 level in different pathological stage of NAFLD;Clinical characteristics of patients being biopsied;

Countries

China

Contacts

Public ContactShujian Guo
shujian.guo@sanofi.com+86 10 65634705

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 12, 2026