SAFETY AND EFFICACY OF SAROGLITAZAR IN PATIENTS WITH NON-OBESE NAFLD: OPEN LABEL RANDOMISED CONTROL TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Improvement in hepatic steatosis as evidenced by CAP at 6 months
研究概览
简要总结
NAFLD has emerged asone of the commonest causes of chronic liver disease globally with a globalprevalence of around 25%. In India, the prevalence of NAFLD is 9 to 53% with apossible rural/urban and geographic divide. There is an intricate bidirectionalrelationship between metabolic comorbidities and NAFLD. As the number ofcomorbidities increases, the risk of having NAFLD increases and also patientwith NAFLD are at a higher risk of having metabolic risk factors. Obesity is the mostimportant risk factor for the development of NAFLD, however one of theintriguing observation is that some patients are non-obese defined by body mass index (BMI <25 kg/m2) in the absence of“significant†alcohol intake.5 This phenotype which was first described inIndians and Chinese has now been recognized worldwide and it is estimated that20-30 % patients are non-obese.
The management of non-obese NAFLD patient is a clinical conundrum. Thestandard of care in patients of the classical phenotype is lifestyleinterventions with a target to achieve a weight loss of 7 to 10% over 6 months.However, since many patients with non-obese NAFLD already have a normal bodyweight, this is not a feasible target option in such patients. Based on thelandmark PIVENS trial, Vitamin E and pioglitazone has been recommended byinternational authorities for the treatment of biopsy proven Non-Alcoholicsteato-hepatitis(NASH), although it is not approved for the same. Recently, onthe basis of real world data and EVIDENCES II and IV data, drug controllergeneral of India has approved saroglitazar for the treatment of NAFLD with F1to F3 fibrosis, NAFLD with metabolic comorbidities and biopsy proven NASH. However,the role of pharmacotherapy in patients with non-obese NAFLD per se has neverbeen evaluated. Hence, we aim to study the safety and efficacy of saroglitazar inpatients with lean NAFLD in an open labelled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Patients with normal BMI (>18 to < 25 kg/m2) diagnosed as NAFLD defined by the presence of hepatic steatosis on ultrasound or using CAP parameters (of FibroScan) in absence significant consumption of alcohol (<20g/day) irrespective of gender after ruling out other etiologies of other etiologies for hepatic steatosis or elevated transaminases including but not limited to chronic viral hepatitis, autoimmune Hepatitis, hemochromatosis, Wilson disease, celiac disease, drug induced liver injury (DILI), etc.
- •and having LSM <13.6 kPa.
排除标准
- •Patients with BMI ≥ 25 kg/m2, age <18 years or >75 years of age.
- •Patients with concomitant other etiologies for hepatic steatosis or elevated transaminases.
- •Patients already on Vitamin E or pioglitazone.
- •Pregnant or lactating.
- •Patients too sick or not consenting to participate in the study.
结局指标
主要结局
Improvement in hepatic steatosis as evidenced by CAP at 6 months
时间窗: 6 months
次要结局
- 1. Improvement in steatohepatitis as evidenced by FibroScan-AST score (FAST) score at 6 months(2. Improvement in hepatic fibrosis at 6 months by non-invasive parameters [Liver stiffness measurement(LSM), AST to Platelet Ratio (APRI), FIB4])