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.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage change in serum ALT
研究概览
简要总结
To investigate the efficacy of saroglitazar in the prevention of NAFLD in liver transplant recipients who are at high risk of developing NAFLD (diabetes mellitus, dyslipidemia, hypertriglyceridemia, and obesity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults>18 <75 years of age.
- •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
- •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.
结局指标
主要结局
Percentage change in serum ALT
时间窗: at week 24
次要结局
- Reduction in ALT by 25%(by week 24)
- Treatment emergent adverse events with causality assessment(by 24 weeks)
- Incremental cost effectiveness ratio (ICER)(by 24 weeks)
研究者
研究点 (1)
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