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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (1 locations)

    1

    Institute of Liver and Biliary Sciences

    New Delhi, National Capital Territory of Delhi, India, 110070