CTRI/2023/05/053326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)
Zydus Lifesciences Limited (formerly Cadila Healthcare Limited)37 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2023年3月7日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 37
- 主要终点
- Change in liver stiffness measurement performed by transient elastography and Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
研究概览
简要总结
| This study is a phase 4, non-randomised, multicentre, open-label study. The study will be conducted at multiple study centres across India. The study is planned to enroll approximately 1500 patients. This is Open-label Treatment Phase (364days/52 weeks) study. |
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female patients aged ≥18 years 2.Patients who have been prescribed Saroglitazar for NAFLD will be included in this Phase 4 study (patients who use Saroglitazar for the first time) 3.Patients able to and willing to provide written informed consent and comply with the requirements of the study protocol 4.Patients with a prior documented diagnosis of NAFLD based on the AASLD criteria (Refer Appendix III for diagnostic 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: a.Liver stiffness through transient elastography, an LSM ≥8 kPa OR b.Serum ALT ≥45 U/L.
排除标准
- •1.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.
- •2.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis.
- •3.Patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging.
- •4.Contraindications to Saroglitazar or any disease conditions affecting the ability to evaluate the effects of Saroglitazar.
- •5.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.
- •6.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.
结局指标
主要结局
Change in liver stiffness measurement performed by transient elastography and Frequency and severity of treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs)
时间窗: Baseline to Week 52
次要结局
- Change in serum ALT value(Baseline to Week 24 and Week 52)
- Change in serum AST(Baseline to Week 24 and Week 52)
- Change in serum ALP value(Baseline to Week 24 and Week 52)
- Change in TG, HDL-C, LDL-C and non HDL-C levels(Baseline to Week 24 and Week 52)
- Change in body weight and BMI(Baseline to Week 24 and Week 52)
- To evaluate the safety of Saroglitazar 4 mg once daily in the study population(Baseline to Week 52)
研究者
研究点 (37)
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