Safety and preliminary clinical activity of Yarrowia lipolytica lipase (MS1819) in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis

• Conditions: Exocrine pancreatic insufficiency resulting from chronic pancreatitis; MedDRA version: 12.1Level: LLTClassification code 10033628Term: Pancreatic insufficiency

• Registration Number: EUCTR2010-018900-10-FR
• Lead Sponsor: aboratoires Mayoly Spindler

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

•Male or female subjects = 18 years of age
•Adequate diagnosis of Chronic Pancreatitis
•Evidence of Exocrine Pancreatic Insufficiency as confirmed by fecal elastase levels < 100 µg/g stool
•History of steatorrhea = 7g/24h (without pancreatic enzymes replacement)
•Patients must be naïve of pancreatic enzymes or on optimal dose of enzymes prior to entry in the study
•Clinically stable with no evidence of an acute medical condition as evidenced by : medical and medication history, baseline physical examination including vital signs and laboratory analysis
•Patients with chronic pancreatitis due to alcohol abuse can be enrolled provided that they show no clinical symptoms of recent alcohol consumption and no alcohol withdrawal symptoms
•Females of childbearing potential must use an effective method of contraception (double method contraception) during the study
•Females of childbearing potential must have a negative urine pregnancy test at screening
•Provide written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•History of fibrosing colonopathy, decompensated cirrhosis, portal hypertension, liver transplant or lung transplant
•Significant bowel resection
•Acute pancreatitis or recent exacerbation of chronic pancreatitis
•Hepatic enzymes (AST, ALT ,Ph Alkalines) > 3 times the upper limit of normal range
•Active or recurrent malignant pancreatic tumor
•Patient unable to discontinue the use of pancreatic enzymes
•Patients who use bowel stimulant and/or laxatives on a regular basis
•Participation in an investigational drug study, biologic, or device not currently approved for marketing within 30 days prior to the Screening Visit
•Any other condition that the investigator believes would interfere with the intent of this study or would make study participation not in the best interest of the subject
•Female who are pregnant or breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To document MS1819 safety profile in EPI patients due to chronic pancreatitis;Secondary Objective: To show preliminary data on MS1819 efficacy in improving dietary fats malabsorption in patients with malabsorption syndrome due to exocrine pancreatic insufficiency resulting from chronic pancreatitis. ;Primary end point(s): Safety assessment: <br>Clinical and biological adverse events, MS1819 plasma detection and anti MS1819 antibodies determination.<br>