Saroglitazar magnesium in preventing Fatty liver disease in post live donor liver transplant recipients.
- Conditions
- Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Adults >18 <75 years of age.
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.
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) <18 kg/m².
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage change in serum ALTTimepoint: at week 24
- Secondary Outcome Measures
Name Time Method 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