CTRI/2023/08/056008尚未招募4 期
Safety and efficacy of Saroglitazar magnesium in live donor liver transplant recipients in preventing Non-alcoholic fatty liver disease (NAFLD): a pilot randomized placebo-controlled trial double- blinded trial. - Nil
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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