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Trial from ANZCTR

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.

  • Recruitment status at the time of last update
    Recruiting
  • What is the status of the ethics application?
    Ethics status: Approved
  • Prospective – trial registered prior to recruitment of first participant.

    Retrospective – trial registered after recruitment of first participant.
    Prospectively registered
  • Has the trial been updated in the last 12 months?
    Up to date
    (Last updated: 1/2/2017)
  • Ethics status: Approved
    What is the status of the ethics application?
  • Up to date
    Has the trial been updated in the last 6 months?
Key trial Information

Trial ID

ACTRN12616000962437

Date registered

21 July 2016

Health condition

Exocrine pancreatic insufficiency (EPI) caused by chronic pancreatitis (CP) , Exocrine pancreatic insufficiency (EPI) caused by distal pancreatectomy.

Recruitment countries

Australia, New Zealand, New Zealand

Recruitment site location(s) (State)

South Australia, Western Australia

Recruitment status

Recruiting

Anticipated date of first participant enrolment

28 November 2016

Ethics application status

Approved

Brief summary

This is a Phase IIa study, testing a new medication for chronic pancreatitis. The new medication is called MS1819-SD which is a modified version of a naturally occurring enzyme made in the pancreas.

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 planned MS1819-SD doses in these treatment periods are 280 mg/day, 560 mg/day, 1120 mg/day and 2240 mg/day.

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.

The eligible patients will be required to washout from porcine pancreatic extracts before commencing on the lowest of four daily doses of MS1819SD for four days (drug taken orally, five times a day). Participants will complete four treatment periods, with the daily dose of MS1819SD increasing in each treatment period.

Safety will be assessed at the end of each treatment period with particular attention paid to immunoallergic effects, digestive symptoms and clinical laboratory tests.

The secondary purpose of this study is to investigate the efficacy of MS1819SD
in patients with chronic pancreatitis by analysis of coefficient of fat absorption (CFA) and change from baseline.

Participants will be required to complete five day stool collections following high fat
meals at the end of the washout period and at the end of each treatment phase.

This study is being sponsored by AzurRx (the Sponsor). The Sponsor will fund researchers who conduct this research for the use of their facilities and to conduct this study.

Eligibility

Key inclusion criteria

Patients with established Exocrine Pancreatic Insufficiency (EPI) associated to Chronic Pancreatitis (CP) and/or pancreatectomy that fulfill the following criteria will be included:

1. Signed and dated informed consent form
2. Age 18 years and older,
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 less than 100 micro g/g of stools at screening,
7. Coefficient of Fat Absorption (CFA) measurement less than or equal to 75% at washout of phase B,
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.

Minimum age

18 Years

Maximum age

No limit

Gender

Both males and females

Key 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 for more than or equal to 1 meter length, etc.,
6. Acute pancreatitis or exacerbation of CP for less than or equal to 3 months,
7. Pancreatectomy for exocrine or endocrine cancer for less than or equal to 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 greater than3 times ULN (upper limit normal),
11. ALT or AST greater than 3 times ULN,
12. Alkaline phosphatase greater than 3 times ULN,
13. Gamma glutamyl transferase greater than 5 times ULN,
14. Patients with a known allergy to the stool marker,
15. Lactation or known pregnancy or positive pregnancy test at both screening and baseline for women of childbearing potential,
16. Drug addiction that would preclude participation and compliance with study procedures,
17. Chronic alcoholic intoxication that would preclude compliance with study procedures and/or intoxication greater than 50 grams alcohol/day,
18. Participation in another clinical study involving an Investigational Medicinal Product (IMP) within 30 days prior to inclusion or concomitantly with this study.

Contact details and further information

Primary Sponsor

Type: Commercial sector/Industry
Name: INC Research Australia Pty Ltd
Address: 159 Port Road Hindmarsh
South Australia 5007
Australia
Country: Australia

Contact person for information and recruitment

Ms Zoe Harrison
CMAX, Level 5
18a North Terrace
Adelaide 5000, SA

Australia
+61 8 7088 7900
zoe.harrison@cmax.com.au