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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018900-10-FR

Enrollment

Registered

2010-03-19

Start date

2010-05-11

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exocrine pancreatic insufficiency resulting from chronic pancreatitis MedDRA version: 12.1 Level: LLT Classification code 10033628 Term: Pancreatic insufficiency

Interventions

Product Name: MS1819 Product Code: MS1819 Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Yarrowia lipolytica lipase Current Sponsor code: MS1819 Concentration unit: mg milligram(s)

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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: Clinical and biological adverse events, MS1819 plasma detection and anti MS1819 antibodies determination.	—

Measure

Time frame

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: Clinical and biological adverse events, MS1819 plasma detection and anti MS1819 antibodies determination.

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026