A Phase 3 Prospective, Multicenter, Randomized, Double-blind Studyof Saroglitazar 4 mg Versus Placebo in Patients with NonalcoholicFatty Liver Disease.

Cadila Healthcare Limited0 个研究点目标入组 68 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1.Males or females, 18 to 65 years of age.
•2. Diagnosis of NAFLD established either by imaging [ultrasound, computed tomography
•(CT) scan or magnetic resonance imaging (MRI)] or liver biopsy showing simple
•steatosis, within 6 months of the Screening Phase for this study. The diagnosis of
•NAFLD is made according to the American Association for the Study of Liver Diseases
•(AASLD) criteria (Chalasani et al. Hepatology 2012; 55:2005-2023).
•(a) hepatic steatosis by imaging or histology,
•(b) no significant alcohol consumption,
•(c) no competing etiologies for hepatic steatosis, and
•(d) no co-existing causes for chronic liver disease.
•3. Patients with steatosis >= 10 % as assessed by MRI at the Screening.
•4. ALT level of >= 1.5 Ã? ULN at screening.
•5. Patientâ??s demonstration of understanding of study requirements and treatment
•procedures, willingness to comply with all protocol-required evaluations; provision of
•written informed consent form before any study specific tests or procedures are

•1.Use of vitamin E ( >400 IU/day) or multivitamins containing vitamin E ( >400 IU/day)
•in the 3 months preceding enrollment.
•2.Use of drugs with potential effect on NAFLD/NASH such as ursodeoxycholic acid,
•S-adenosylmethionine (SAM-e), betaine, pentoxifylline 1 month prior to enrollment.
•3.Fibrates (clofibrate, fenofibrate) in the 3 months prior enrollment.
•4.Use of thiazolidinedione (pioglitazone, rosiglitazone).
•5.History of bowel surgery (gastrointestinal (bariatric) surgery or undergoing
•evaluation for bariatric surgery for obesity, extensive small-bowel resection, or
•orthotopic liver transplant (OLT) or listed for OLT.
•6.History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis,
•cholestatic and metabolic liver diseases) and hemochromatosis.
•7.Patient has known cirrhosis, either based on clinical criteria or liver histology or
•FibroscanÂ®.
•8.Patient with International normalized ratio (INR) >1.3.
•9.Type 1 diabetes mellitus.

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