A multicentre open-label phase IIa study with escalating dose of MS1819-SD, to investigate the efficacy and safety of a Yarrowia lipolytica lipase preparation for the compensation of exocrine pancreatic insufficiency caused by chronic pancreatitis and/or distal pancreatectomy.

INC Research Australia Pty Ltd0 个研究点目标入组 13 人开始时间: 2016年7月21日最近更新: 2020年1月13日

研究概览

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•1.Signed and dated informed consent form,
•2.Age 18 years and older,
•3.Male or female,
•4.Body weight within the range [50-100 Kg] for males or [40-90 Kg] for females,
•5.Distal pancreatectomy for any disorder (e.g. acute pancreatitis or its complications, CP or its complications, pancreatic endocrine or exocrine cancer, or others) and/or CP of any etiology (e.g. alcohol, genetics, hypercalcemia, or others) of grade 2 or higher (Cambridge classification),
•6.Faecal pancreatic elastase-1 less than 100 micro g/g at screening or within one month of the screening visit,
•7.CFA measurement less than or equal to 75% at washout,
•8.Female patients must be post-menopausal (defined as at least 12 months post cessation of menses), surgically sterile or, if of childbearing potential, using a reliable method of contraception during the study.
•9.Being considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator.

•1.Cystic fibrosis,
•2.Total or partial gastrectomy,
•3.Cephalic or total duodenopancreatectomy,
•4.Documented fibrosing colonopathy,
•5.Any small bowel disease possibly responsible for malabsorption, including small intestinal bacterial overgrowth, celiac disease, small bowel resection greater than or equal to 1 meter length, etc.,
•6.Acute pancreatitis or exacerbation of CP less than or equal to 3 months,
•7.Pancreatectomy for exocrine or endocrine cancer less than or equal to 1 year,
•8.Metastatic or locally recurrent exocrine pancreatic cancer,
•9.Known hypersensitivity or other severe reaction to any ingredient of the investigational medicinal product,
•10.Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential,

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