Fatty Liver Disease Collaborative Research in China

Non-alcoholic Fatty Liver Disease Clinical Trial

— FLDCR  

Official title:

A Multi-center, Prospective Cohort Study on the Natural History of Fatty Liver Disease in China

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02391168
• Other study ID #: FLD2015
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2015
• Last updated: August 3, 2015
• Start date: July 2015
• Est. completion date: December 2020

Study information

• Verified date: August 2015
• Source: Fatty Liver and Alcoholic Liver Disease Study Group, China
• Contact: Jiangao Fan, MD
• Email: fattyliver2004[@]126.com
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A multi-center, prospective cohort study on the natural history of fatty liver disease in China

Description:

This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with liver biopsy-proven macrovesicular steatosis (>5%) will be enrolled in the baseline cross-sectional analysis. Those who are either diagnosed as NAFLD or ALD, if meeting all the inclusion and exclusion criteria, will be enrolled in the following cohort study, will be followed up after 1 year, 3 years and 5 years with a visit window of +1 month.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinically diagnosed fatty liver disease, confirmed by liver biopsy.

• Specific biopsy requirements: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.

• Only patients with NAFLD or ALD are eligible for the 5-year follow-up cohort study.

• Willing to participate in the long-term follow-up and cooperative.

• Able to provide informed consent file.

Exclusion Criteria:

• Unable to provide informed consent.

• Patients are eligible for baseline cross-sectional analysis but not eligible for the cohort section, if having any of the following condition:

1. Any end-stage liver disease.

2. Any malignant tumor.

3. Any infection of hepatitis virus or HIV.

4. Any congenital liver disease such as Wilson disease.

5. Any other serious disease of projected survival < 5 years.

6. Combined NAFLD and ALD.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fatty Liver
• Fatty Liver, Alcoholic
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang
China	Shandong Provincial Hospital	Ji'nan	Shandong
China	Shanghai Xinhua Hospital	Shanghai
China	Tianjin Second People's Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang
China	Zhangzhou Zhengxing Hospital	Zhangzhou	Fujian

Sponsors (2)

Lead Sponsor	Collaborator
Fatty Liver and Alcoholic Liver Disease Study Group, China	Unimed Scientific Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver cirrhosis		5 years	No
Secondary	liver cancer		5 years	No
Secondary	liver failure		5 years	No
Secondary	type 2 diabetes		5 years	No
Secondary	cardiovascular and cerebrovascular events		5 years	No
Secondary	death		5 years	No