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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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18 April 2017 |
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Main ID: |
ChiCTR-OOC-16007902 |
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Date of registration:
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2016-02-05 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Clinical Study Evaluating the Association between NASH/Fibrosis and Metabolic
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Scientific title:
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A Clinical Study Evaluating the Association between NASH/Fibrosis and Metabolic |
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Date of first enrolment:
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2016-05-23 |
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Target sample size:
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NA:480; |
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Recruitment status: |
Recruiting |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=13350 |
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Study type:
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Observational study |
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Study design:
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Cross-sectional
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Phase:
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Other
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Countries of recruitment
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China
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Contacts
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Name:
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Shujian Guo
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Address:
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3F, HNA Building, 108 Jianguo Road, Chaoyang District, Beijing
100022
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Telephone:
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+86 10 65634705 |
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Email:
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shujian.guo@sanofi.com |
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Affiliation:
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Name:
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Sanofi
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Address:
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19F Tower III, Kerry Center, 1228 Middle Yan'an Road, Jing'an District, Shanghai
200040
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Telephone:
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+86 21 22266622 |
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Email:
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contact-us.cn@sanofi.com |
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Affiliation:
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SANOFI (CHINA) INVESTMENT CO., LTD. SHANGHAI BRANCH |
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
18
Age maximum:
65
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Nonalcoholic fatty liver disease
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Primary Outcome(s)
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Percentage of NASH/ fibrosis in NAFLD patients confirmed by liver biopsy with or without MS;
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Secondary Outcome(s)
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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;
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Source(s) of Monetary Support
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Sanofi (Beijing) Pharmaceutical Co., Ltd.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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