Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Conditions
Interventions
Intervention1: Saroglitazar magnesium: Saroglitazar 4mg OD 60 minutes before breakfast for 24 weeks
Control Intervention1: Placebo: Matched placebo for a period of 24 weeks.
Sponsors
Amrita Institute Of Medical Sciences Research Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults >18 2. Patients who are at least 6 months post-transplant with normal liver function but are diabetic and have either diabetes mellitus, dyslipidemia and hypertriglyceridemia or obesity 3. History of medical compliance with immunosuppression.
Exclusion criteria
Exclusion criteria: Patient with abnormal transaminases due to a. Biopsy proven rejection b. Clinical rejection c. Vascular complication d. Biliary complication Patients with graft dysfunction due to any cause Body mass index (BMI) History of myopathies or evidence of active muscle diseases. Unstable cardiovascular disease. History of bladder disease and/or hematuria or has current hematuria unless due to a urinary tract infection. Active malignancy post-liver transplantation. History of malignancy in the past 5 years and/or active neoplasm. History of chronic rejection of liver transplant graft. History of alcohol intake. Subject tests positive for a urine drug screen. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in serum ALTTimepoint: at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incremental cost effectiveness ratio (ICER)Timepoint: by 24 weeks;Reduction in ALT by 25%Timepoint: by week 24;Treatment emergent adverse events with causality assessmentTimepoint: by 24 weeks | — |
Countries
India
Contacts
Public ContactDr Arun Valsan
Amrita Institute Of Medical Sciences
Outcome results
None listed