MS1819-SD phase IIa clinical trial for patients with exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) and/or distal pancreatectomy.
- Conditions
- Exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP)Exocrine pancreatic insufficiency (EPI) caused by distal pancreatectomy.Metabolic and Endocrine - Other endocrine disordersOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12616000962437
- Lead Sponsor
- INC Research Australia Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 13
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,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective of this Phase IIa study is to investigate the safety of escalating doses of MS1819SD, a spraydried yarrowia lipolytica lipase preparation in people with chronic pancreatitis.[At the end of each treatment phase, safety variables will be monitored by physical examination with particular attention paid to immunoallergic events and digestive symptomatology. In addition, laboratory tests will include immunogenic assessment for circulating levels of LIP2, antibodies against LIP2, hematology and biochemistry.<br>]
- Secondary Outcome Measures
Name Time Method The secondary objective for this study is to investigate the efficacy of MS1819SD<br>in patients with chronic pancreatitis by analysis of coefficient of fat absorption (CFA)and change from baseline. [Key secondary endpoints such as the number of evacuations, stools consistency and stools weight during the stools collection period will be assessed.]