NCT07249788招募中4 期
Clinical Evaluation of Safety and Efficacy of Resmiterom in Patients With MASH (Metabolic Dysfunction-Associated Steato-Hepatitis) A Prospective, Open-label, Interventional Study
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- FIB-4 and CAP score/LSM on fibroscan
研究概览
简要总结
Phase 4 clinical trial study aims to further evaluate the safety and therapeutic efficacy of Resmetirom in Pakistani patients with fibroscan proven MASH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• At least one metabolic comorbidity (e.g., T2DM, obesity, dyslipidemia and hypertension)
- •Clinical diagnosis of MASH using:
- •LSM ≥ 8.5kpa And/or
- •FAST score ≥0.67 And/or
- •FibroScan CAP ≥ 275 dB/m And/or
- •FIB-4 > 1.3
排除标准
- •• History of drug addiction and alcoholism
- •Cirrhosis or decompensated liver disease
- •Chronic viral hepatitis HBV, HCV)
- •MACE including MI, Stroke, PE etc.
- •Pregnant/lactating women
- •Concurrent use of other investigational drugs
- •History of other liver diseases (viral, autoimmune, drug-induced, alcohol)
- •Previous use of resmetirom in last 6 months
- •Significant renal impairment (eGFR <30)
研究组 & 干预措施
MASH targeted therapy
Experimental
MASH fibrosis stage 2 or 3
干预措施: Resmetirom (Drug)
结局指标
主要结局
FIB-4 and CAP score/LSM on fibroscan
时间窗: 6 months
Changes in liver fibrosis using non invasive markers
Changes in thyroid profile
时间窗: 6 months
thyroid profile of each patient at baseline and at primary end point
次要结局
未报告次要终点
研究者
研究点 (1)
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