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A Phase IIa Study With Escalating Dose of MS1819-SD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03481803
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
AzurRx SAS

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Chronic Pancreatitis Distal Pancreatectomy Drug: MS1819-SD Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Sequential Assignment Eligible patients will be receiving increased doses from lower, middle to upper range of study medication MS1819-SD
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 27, 2017
Actual Primary Completion Date : June 29, 2018
Actual Study Completion Date : June 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis


Intervention Details:
  • Drug: MS1819-SD
    Patient will receive increasing doses from the lowest dose of MS1819-SD to a maximum dose of MS1819- SD. The total treatment phase will range from 48 days to 60 days.


Primary Outcome Measures :
  1. 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 ]
    Safety variables will be monitored by physical examination with particular attention paid to immunoallergic events and digestive symptomatology. In addition, laboratory tests will include haematology and biochemistry.


Secondary Outcome Measures :
  1. Investigate the efficacy of MS1819-SD in patients by the Coefficient of Fat Absorption change from baseline [ Time Frame: 60 days ]
    The primary efficacy endpoint is the Coefficient Fat Absorption (CFA) change from baseline.The secondary efficacy endpoints are the number of daily evacuations per day, the consistency of stools assessed by the Bristol scale (from Type 1 to Type 7) and the weight of stools during the stool collection period.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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),

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03481803


Locations
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Australia, Queensland
Mackay Institute of Research and Innovation
Mackay, Queensland, Australia, 4740
Australia, South Australia
CMAX
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Linear Research
Perth, Western Australia, Australia, 6009
France
Hôpital Timone Adulte (CIC-CPCET)
Marseille, France, 13385
New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand, 8011
P3 Research
Wellington, New Zealand, 6242
Sponsors and Collaborators
AzurRx SAS

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Responsible Party: AzurRx SAS
ClinicalTrials.gov Identifier: NCT03481803     History of Changes
Other Study ID Numbers: MS1819/16/01
First Posted: March 29, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AzurRx SAS:
Exocrine Pancreatic Insufficiency
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Exocrine Pancreatic Insufficiency
Pancreatic Diseases
Digestive System Diseases