Status:
COMPLETED
A Phase IIa Study With Escalating Dose of MS1819-SD
Lead Sponsor:
AzurRx SAS
Conditions:
Chronic Pancreatitis
Distal Pancreatectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Signed and dated informed consent form,
- Age \>18 years,
- Male or female,
- Body weight within the range \[50-100 Kg\] for males or \[40-90 Kg\] for females,
- 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),
- Faecal pancreatic elastase-1 \<100 μg/g of stools at screening or within one month of the screening visit,
- CFA measurement ≤ 75% at washout
- 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.
- Being considered as reliable and capable of adhering to the protocol, according to the judgment of the investigator.
Exclusion
- Cystic fibrosis,
- Total or partial gastrectomy,
- Cephalic or total duodenopancreatectomy,
- Documented fibrosing colonopathy,
- Any small bowel disease possibly responsible for malabsorption, including small intestinal bacterial overgrowth, celiac disease, small bowel resection ≥1 meter length, etc.,
- Acute pancreatitis or exacerbation of CP ≤3 months,
- Pancreatectomy for exocrine or endocrine cancer ≤1 year,
- Metastatic or locally recurrent exocrine pancreatic cancer,
- Known hypersensitivity or other severe reaction to any ingredient of the investigational medicinal product,
- Bilirubin \>3 times ULN (upper limit normal),
Key Trial Info
Start Date :
January 27 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2018
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT03481803
Start Date
January 27 2017
End Date
June 29 2018
Last Update
September 28 2018
Active Locations (6)
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1
Mackay Institute of Research and Innovation
Mackay, Queensland, Australia, 4740
2
CMAX
Adelaide, South Australia, Australia, 5000
3
Linear Research
Perth, Western Australia, Australia, 6009
4
Hôpital Timone Adulte (CIC-CPCET)
Marseille, France, 13385