NCT05872269招募中4 期
A Phase 4, Non-randomized, Multicentre, Open-label, Single-arm Study to Evaluate the Safety and Efficacy of Saroglitazar 4 mg in Patients With Non Alcoholic Fatty Liver Disease (NAFLD) With Comorbidities (Either Obesity, Type 2 Diabetes Mellitus, Dyslipidemia or Metabolic Syndrome)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 19
- 主要终点
- Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
研究概览
简要总结
A Phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
详细描述
The study is being planned to evaluate long term safety and efficacy of Saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (NAFLD).
Total 1500 male and female patients with NAFLD with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥18 years
- •Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time)
- •Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol
- •Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria. NAFLD is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. In addition, patients must have one of the following criteria to indicate ongoing NAFLD at screening:
- •Liver stiffness through transient elastography, an LSM ≥8 kPa OR
- •Serum ALT ≥45 U/L
排除标准
- •Consumption of alcohol for at least 90 consecutive days in last one year: >2 units of alcohol per day (>14 units per week) for males and >1 unit of alcohol per day (>7 units per week) for females. Note: 1 unit = 360 mL of beer, or 120 mL of wine, or 30 mL of spirits/hard liquor
- •History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
- •Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
- •Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
- •History or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study.
- •Any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation.
- •Women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study.
- •Pregnant or breast feeding females
研究组 & 干预措施
Saroglitazar 4 mg tablets
Experimental
Oral (once daily ) during 364 days/52 weeks of treatment period.
干预措施: Saroglitazar (Drug)
结局指标
主要结局
Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
时间窗: Baseline to Week 52
Change in liver stiffness
时间窗: Baseline to Week 52
liver stiffness measurement performed by transient elastography
次要结局
- Change in TG, HDL-C, LDL-C and non HDL-C levels(Baseline to Week 24 and Week 52)
- Change in serum ALT value(Baseline to Week 24 and Week 52)
- Change in serum AST value(Baseline to Week 24 and Week 52)
- Change in serum ALP value(Baseline to Week 24 and Week 52)
- Change in body weight(Baseline to Week 24 and Week 52)
- Change in BMI(Baseline to Week 24 and Week 52)
研究者
研究点 (19)
Loading locations...
相似试验
已完成
4 期
A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)Juvenile Idiopathic ArthritisNCT03301883Hoffmann-La Roche62
已完成
4 期
Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast CancerBreast CancerNCT02445586Hoffmann-La Roche52
已完成
4 期
Brilinta DaYu StudyAcute Coronary SyndromeNCT01870921AstraZeneca2,004
已完成
4 期
A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a TaxaneHER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast CancerNCT02658734Hoffmann-La Roche70
已完成
4 期
Dupilumab in Japanese Patients With Chronic Rhinosinusitis With Nasal Polyp (SINUS-M52)Chronic Rhinosinusitis With Nasal PolypsNCT05049122Sanofi25