Efficacy of Saroglitazar in patients with Metabolic Dysfunction Associated Steatotic Liver Disease With Associated Etiology of Steatotic Liver Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Improvement in hepatic steatosis as evidenced by CAP at 6 months in patients with MASLD with/without associated etiology
研究概览
简要总结
Saroglitazar may have beneficial role in NAFLD with significant fibrosis. No studies have analyzed the role of saroglitazar in MASLD with associated etiology . We will conduct this study in order to study efficacy of saroglitazar in patients with Met ALD and MASLD with associated etiologies. Treatment response will be compared between MASLD and MASLD with associated etiologies. We will compare with response of saroglitazar in patients with pure MASLD and multiple etiology SLD. We will also assess the role of saroglitazar in improvement of fibrosis and steatosis in patients with MASLD with associated etiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •Patients in all above categories having with liver stiffness measurement (LSM) on VCTE (Fibroscan) of more than 8kPa and less than 13.6 kPa.
排除标准
- •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).
结局指标
主要结局
Improvement in hepatic steatosis as evidenced by CAP at 6 months in patients with MASLD with/without associated etiology
时间窗: Assessment will be done at baseline, 3 months and 6 months
次要结局
- 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)