Identifying risk factors for liver fibrosis in relatives of patients with NASH-related cirrhosis
Risk Factors of Liver Fibrosis Among First Degree Relatives of Patients With NASH Related Cirrhosis (NRC).
This study is trying to find out what factors might increase the risk of liver fibrosis in family members of people with NASH-related cirrhosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 670 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institute of Liver and Biliary Sciences, India Academic / other |
| Drugs / interventions | chemotherapy, methotrexate |
| Locations | 1 site (New Delhi, Delhi) |
| Trial ID | NCT04057287 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify risk factors for liver fibrosis among first-degree relatives of patients diagnosed with NASH-related cirrhosis. It consists of two parts: a cross-sectional study to assess the relatives and a case-control study comparing NASH cirrhosis patients with healthy controls and HBV disease controls. Data will be collected through questionnaires, blood tests, and imaging techniques to evaluate various health parameters and lifestyle factors. The study will enroll participants from the Institute of Liver and Biliary Sciences over a three-year period.
Who should consider this trial
Good fit: Ideal candidates include first-degree relatives of patients with NASH-related cirrhosis aged 8 years and older.
Not a fit: Patients with acute on chronic liver failure or those with specific liver diseases such as HBV or HCV will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help identify individuals at risk for liver fibrosis, allowing for earlier intervention and management.
How similar studies have performed: While similar studies have explored liver fibrosis risk factors, this specific approach focusing on first-degree relatives is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
New Delhi, Delhi
- Institute of Liver and Biliary Sciences — New Delhi, Delhi, India (Recruiting)
Study contacts
- Principal investigator: Dr Ankit Bhardwaj, Masters-CR — Institute of Liver and Biliary Sciences
- Study coordinator: Dr Ankit Bhardwaj, Masters-CR
- Email: bhardwaj.ankit3@gmail.com
- Phone: 01146300000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.