Chronic Pancreatitis Clinical Trial
Official title:
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
This is a Phase IIa study sponsored by AzurRx SAS and Syneos Health is a local representative
sponsor and involves testing of a new medication for the compensation of exocrine pancreatic
insufficiency (EPI) caused by chronic pacreatitis (CP) and/or distal pancreatectomy. The new
medication is called MS1819 Spray Dried (MS1819-SD) which is a lipase produced by the LIP2
gene of Yarrowia lipolytica using recombinant DNA technology.
The primary purpose of this study is to investigate the safety of escalating doses of study
drug MS1819-SD in people with chronic pancreatitis. This enzyme has demonstrated an
appropriate profile to compensate the pancreatic lipase (enzyme) deficiency that is common
with CP patients. The deficiency in this enzyme can be responsible of greasy diarrhea, fecal
urge and weight loss.
The design of the study is open-label, meaning that all eligible participants will receive
the study drug MS1819-SD. The MS1819-SD dose will increase throughout the study during dose
escalation visits in each treatment period; study includes a total of four treatment periods.
The total duration of the MS1819-SD treatment phase is of 48-60 days, The total duration of
patient participation in the study is of 74-93 days.
Approximately twelve patients will be enrolled in this study.
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