NCT03639623已完成2 期
A Phase 2A, Single Center, Open-label, Single-arm, 24-week Study to Evaluate the Safety, Tolerability and Efficacy of Saroglitazar Magnesium 4 mg in Liver Transplant Recipients With Nonalcoholic Fatty Liver Disease (EVIDENCES VIII)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events Assessed by CTCAE
研究概览
简要总结
This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.
详细描述
This is a phase 2A, single center, open-label, single-arm, 24-week study to evaluate the safety, tolerability and efficacy of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD.
The study will be conducted over a period of up to 33 weeks and will include 5 weeks screening, a 24 week treatment period and 4 week follow-up period. The primary end point of the study is to assess the safety of Saroglitazar Magnesium 4 mg in liver transplant recipients with NAFLD over 24 weeks of treatment.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to give written informed consent.
- •Males or females, 18 to 75 years of age.
- •Patients who are at least 6 months post-transplant for nonalcoholic steatohepatitis (NASH) or cryptogenic cirrhosis thought to be secondary to NASH are eligible for enrolment.
- •The presence of NAFLD determined by Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF) prior to enrollment.
- •Patients with ≤20% variance in the levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and total bilirubin between Visit 1 and Visit 1.
- •History of medical compliance with immunosuppression.
- •Female subjects of non-child bearing potential or on highly effective contraception. For male subjects with female partners of childbearing potential, willing to follow highly effective contraception measures during the study, either by the male participant or his female partner or both.
排除标准
- •Pregnant or lactating females.
- •Patient with abnormal transaminases due to secondary intercurrent illness.
- •Patients with bile duct strictures.
- •Other causes of chronic liver disease after liver transplantation including autoimmune, viral, and alcoholic liver disease.
- •Graft cirrhosis as defined by:
- •Cirrhosis on historical liver biopsy.
- •Evidence of cirrhosis on imaging including portal venous collaterals.
- •Prior history of decompensated liver disease including ascites, hepatic encephalopathy or variceal bleeding.
- •Evidence of esophageal varices on prior endoscopy.
- •Body mass index (BMI) <18 kg/m².
- •Subjects with change in body weight >5% in the 3 months prior to enrollment.
- •Subjects requiring corticosteroid or anticoagulation therapy.
- •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.
- •Acute cellular rejection of liver transplant graft within the past 6 months.
- •Evidence of Acute cellular rejection (ACR) or chronic rejection (CR) or alternative etiologies to NAFLD.
- •Poorly controlled diabetes as defined by an HbA1c >8.5% within the past 6 months.
- •History of excessive alcohol intake.
- •Subject tests positive for a urine drug screen.
- •Subject has a history of chronic (uncontrolled) pain.
研究组 & 干预措施
Saroglitazar Magnesium 4 mg
Experimental
Saroglitazar Magnesium tablet once daily in the morning 60 minutes before breakfast
干预措施: Saroglitazar (Drug)
结局指标
主要结局
Number of Participants With Adverse Events Assessed by CTCAE
时间窗: 24 weeks
Safety measured by adverse events, vital signs, physical exams, body weight, electrocardiograms (ECGs) and lab results (including hematology, chemistry and urinalysis)
次要结局
- Hepatic Fat(Baseline and week 24)
- Liver Stiffness(Baseline and Week 24)
- Frequently Sampled Intravenous Glucose Tolerance Test (Insulin Resistance Marker)(Baseline and Week 24)
- Glycosylated Hemoglobin (Insulin Resistance Marker)(Baseline and Week 24)
- Fructosamine (Insulin Resistance Marker)(Baseline and Week 24)
- Serum Liver Enzymes(Baseline and Week 24)
- Serum Liver Enzymes; Bilirubin(Baseline and Week 24)
- Serum Lipids(Baseline and Week 24)
- Small Dense Low-density Lipoprotein (Atherogenic Lipoprotein)(Baseline and Week 24)
- LDL Size (Atherogenic Lipoprotein)(Baseline and Week 24)
- LDL Concentration (Atherogenic Lipoprotein)(Baseline and Week 24)
- Very Low-density Lipoprotein (Atherogenic Lipoprotein)(Baseline and Week 24)
- Very Low-density Lipoprotein Chylomicron Triglyceride (Atherogenic Lipoprotein)(Baseline and Week 24)
- High-density Lipoprotein (Atherogenic Lipoprotein)(Baseline and Week 24)
- Change in Metabolic Flexibility; Time to Peak RQ(Baseline and Week 24)
- Quality of Life (SF-36 Health Survey)(Baseline and Week 24)
- Peak Plasma Concentration [Cmax](PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Time to Reach Peak Plasma Concentration [Tmax](PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Area Under Plasma Concentration vs. Time Curve Till the Last Time Point [AUC0-t](PK Sampling time points: Day 1 visit at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Area Under Plasma Concentration vs. Time Curve Extrapolated to the Infinity [AUC0-∞](PK Sampling time points: Day 1 visit at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Area Under Plasma Concentration vs. Time Curve in a 24 h Dosing Interval [AUCtau](PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Elimination Rate Constant [λz](PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Elimination Half-life [t1/2](PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Apparent Volume of Distribution [Vd/F](PK Sampling time points: Day 1 (Baseline) and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Apparent Clearance [CL/F](PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Minimal or Trough Plasma Concentration [Cmin](PK Sampling time points: Week 24 visit at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Accumulation Index Calculated as a Ratio of AUCtau (Last Dose)/AUCtau (First Dose)(PK Sampling time points: Day 1 and Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
- Fluctuation Index(PK Sampling time points: Week 24 visits at pre-dose (0), 0.5, 1.0, 2, 3, 4, 6, 8, 10 and 24-hour post-dose)
研究者
研究点 (1)
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