Status:
UNKNOWN
Risk Factors of Liver Fibrosis Among First Degree Relatives of Patients With NASH Related Cirrhosis (NRC)
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhoses
Eligibility:
All Genders
18+ years
Brief Summary
The study aim to identify the risk factors of liver fibrosis among first degree relatives. This study consists of 2 parts (Cross Sectional and Case Control Study). Part 1: The first primary objective...
Detailed Description
The data will be collected on socio-demographic by (socio-demographic questionnaire), alcohol by AUDIT-C (Alcohol Use Disorders Identification Test), Tobacco by FTND (Fagerstrom Test Nicotine Dependen...
Eligibility Criteria
Inclusion
- Inclusion Criteria for NASH related Cirrhosis (Group 1-Index Case)
- Age ≥18 yrs
- Diagnosed cases of NASH with Cirrhosis.
- Exclusion Criteria for NASH related Cirrhosis (Group 1)
- Acute on Chronic Liver Failure
- Patients with HBV, HCV, Wilson's, Hemochromatosis, alpha 1 antitrypsin deficiency, primary biliary cirrhosis).
- Patient on treatment with amiodarone or methotrexate.
- Patient with any malignancies
- Patient on chemotherapy
- Inclusion Criteria for First Degree Relatives (Group 2)
- Age ≥8 yrs
- All the first degree relatives of index case.
- Exclusion Criteria for First Degree Relatives (Group 2)
- 1\. Alcohol intake
- Inclusion Criteria for Healthy Control (Group 3)
- Age ≥18 yrs
- Subjects with no history of any known liver disease
- Non-Alcoholic
- Matched with Age (+/- 5 yrs.) and Gender
- Exclusion Criteria for Healthy Control (Group 3)
- 1\. None
- Inclusion Criteria for HBV Disease Control (Group 4)
- Age ≥18 yrs
- HBV Cirrhosis
- Matched with Age (+/- 5 yrs.) and Gender
- Exclusion Criteria for HBV Disease Control (Group 4)
- Patient with any malignancies
- HBV related Liver Fibrosis (≤ F3).
Exclusion
Key Trial Info
Start Date :
September 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT04057287
Start Date
September 18 2019
End Date
December 31 2023
Last Update
October 5 2023
Active Locations (1)
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1
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070