Risk Factors of Liver Fibrosis Among First Degree Relatives of Patients With NASH Related Cirrhosis (NRC)

Launched by INSTITUTE OF LIVER AND BILIARY SCIENCES, INDIA · Aug 14, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the risk factors for liver fibrosis, which is a condition where the liver becomes scarred, among first-degree relatives of patients with liver cirrhosis related to a condition called NASH (Non-Alcoholic Steatohepatitis). The study has two parts: one part looks at relatives of patients with NASH-related cirrhosis to find patterns or risk factors that might affect their liver health, while the second part compares patients with NASH cirrhosis to healthy individuals and those with liver cirrhosis from hepatitis B virus (HBV).

To participate, you need to be at least 18 years old if you're a patient with NASH cirrhosis, or at least 8 years old if you are a first-degree relative (like a parent or sibling) of someone with this condition. Healthy individuals aged 18 and older with no history of liver disease can also join as controls. Participants will undergo health assessments, provide blood samples for various tests, and complete questionnaires about their lifestyle and health history. If you're interested in joining or learning more, this trial is currently recruiting participants, and it could help improve understanding of liver health in families affected by this disease.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria for NASH related Cirrhosis (Group 1-Index Case)
• • 1. Age ≥18 yrs
• • 2. Diagnosed cases of NASH with Cirrhosis.
• • Exclusion Criteria for NASH related Cirrhosis (Group 1)
• • 1. Acute on Chronic Liver Failure
• • 2. Patients with HBV, HCV, Wilson's, Hemochromatosis, alpha 1 antitrypsin deficiency, primary biliary cirrhosis).
• • 3. Patient on treatment with amiodarone or methotrexate.
• • 4. Patient with any malignancies
• • 5. Patient on chemotherapy
• • Inclusion Criteria for First Degree Relatives (Group 2)
• • 1. Age ≥8 yrs
• • 2. 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)
• • 1. Age ≥18 yrs
• • 2. Subjects with no history of any known liver disease
• • 3. Non-Alcoholic
• • 4. Matched with Age (+/- 5 yrs.) and Gender
• • Exclusion Criteria for Healthy Control (Group 3)
• • 1. None
• • Inclusion Criteria for HBV Disease Control (Group 4)
• • 1. Age ≥18 yrs
• • 2. HBV Cirrhosis
• • 3. Matched with Age (+/- 5 yrs.) and Gender
• • Exclusion Criteria for HBV Disease Control (Group 4)
• • 1. Patient with any malignancies
• • 2. HBV related Liver Fibrosis (≤ F3).