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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03481803 |
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Date of registration:
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06/03/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Phase IIa Study With Escalating Dose of MS1819-SD
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Scientific title:
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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 |
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Date of first enrolment:
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January 27, 2017 |
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Target sample size:
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11 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03481803 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Australia
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France
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New Zealand
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Signed and dated informed consent form,
2. Age >18 years,
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 <100 µg/g of stools at screening or within one month of
the screening visit,
7. CFA measurement = 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.
Exclusion Criteria:
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 =1 meter
length, etc.,
6. Acute pancreatitis or exacerbation of CP =3 months,
7. Pancreatectomy for exocrine or endocrine cancer =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. Bilirubin >3 times ULN (upper limit normal),
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Pancreatitis
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Distal Pancreatectomy
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Intervention(s)
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Drug: MS1819-SD
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Primary Outcome(s)
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Investigate safety of escalating doses of MS1819-SD as measured by number of participants with adverse events including clinical or laboratory abnormalities
[Time Frame: 60 days]
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Secondary Outcome(s)
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Investigate the efficacy of MS1819-SD in patients by the Coefficient of Fat Absorption change from baseline
[Time Frame: 60 days]
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Secondary ID(s)
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MS1819/16/01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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