Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: SAROGLITAZAR: SAROGLITAZAR IN PATIENTS WITH MASLD WITH ASSOCIATED ETIOLOGY
Intervention2: SAROGLITAZAR: SAROGLITAZAR IN PATIENTS WITH MASLD
Intervention3: Saroglitazar: Saroglitazar was
Sponsors
Department of Hepatology Postgraduate institute of medical education and research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with MASLD: defined by the presence of hepatic steatosis on ultrasound or using controlled attenuation parameters (CAP) (of Fibroscan) together with the presence of at least one of five cardiometabolic criteria . 2.Patients of MASLD with moderate amount of alcohol intake (Met ALD) 3.Patients of MASLD with hepatitis C infection 4.Patients of MASLD with HBV infection 5.Patients of MASLD taking one of the steatogenic drugs 6. Patients in all above categories having with liver stiffness measurement (LSM) on VCTE (Fibroscan) of more than 8kPa and less than 13.6 kPa
Exclusion criteria
Exclusion criteria: 1. Patients of compensated or decompensated cirrhosis 2. Patients with HCC or any other malignancy 3. Patients already on Vitamin E, Saroglitazar or pioglitazone 4. Pregnancy/Lactation and those non pregnant female patients recruited in the study who will conceive during the study period will be excluded from the study. 5. Patients who are too sick to conduct the protocol. 6. Patients with significant ethanol intake (more than 60 g/ day and 50g/day in males and females respectively)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in hepatic steatosis as evidenced by CAP at 6 months in patients with MASLD with/without associated etiologyTimepoint: Assessment will be done at baseline, 3 months and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of improvement in hepatic steatosis as evidenced by CAP at 6 months in patients with MASLD and MASLD with associated etiology of SLD Improvement in fibrosis as evidenced by LSM, APRI, FIB-4, AGILE-3+, AGILE 4 at 6 months in MASLD with associated etiology Improvement in steatosis as evidenced by MRI PDFF and MRE at 6 months Improvement in steatohepatitis as evidenced by FibroScan-AST score (FAST) and MAST score at 6 months Improvement in hepatic fibrosis at 6 months by non-invasive parameters [Liver stiffness measurement (LSM). Improvement in ALT (in those with baseline elevated ALT)Timepoint: 6 months | — |
Countries
India
Contacts
Public ContactSIDDHARTH SHARMA
Postgraduate Institute of Medical Education and Research, Chandigarh
Outcome results
None listed