Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support

• Status: Completed
• Trial end date: 2019-11-21
• Target enrollment: 0
• Participant gender: All

Summary

Part A:once weekly dosing for 4 weeks in patients with short bowel syndrome who require total parenteral nutrition; patients will complete period 1 and after a 6-10 week wash-out, they will enter period 2 (active treatment and placebo); Part B: treatment period 3, is an open label extension to part A and starts after a washout of 6-10 weeks after the last dose in treatment period 2. patients are dosed once weekly for 4 weeks.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GLyPharma Therapeutic; GlyPharma Therapeutics
• Collaborator: VectivBio AG
• Treatments: Glucagon; Glucagon-Like Peptide 1

Criteria

Inclusion Criteria

1. Males and females with SBS secondary to surgical resection of small intestine

2. 18-80 years of age

3. Body Mass Index (BMI) between 16.0 and 32.0

4. Patients with a jejuno- or ileostomy and a faecal wet weight excretion of at least 1500 g/day, as recorded within the last 18 months according to the patient's medical record

5. Parenteral support ≥3 times/week for ≥12 months according to the patient's medical record

6. At least 6 months since last surgical bowel resection

7. Willing to adhere to a defined oral intake of fluids on certain days as required by the protocol (and based on the individual's routine daily consumption)

8. Women of childbearing potential must agree to use an adequate method of contraception during the trial and for 60 days after the end-of-trial visit. Adequate methods of contraception include intrauterine device or hormonal contraception (oral contraceptive pill, depot injections or implant, transdermal depot patch or vaginal ring). To be considered sterilised or infertile, females must have undergone surgical sterilisation (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhoea and confirmed with follicle-stimulating hormone [FSH] test)

Exclusion Criteria

1. Pregnancy or lactation

2. Positive results on the human immunodeficiency virus (HIV), hepatitis B and/or C tests

3. A history of clinically significant intestinal adhesions and/or chronic abdominal pain

4. Require chronic systemic narcotics for treatment of pain that exceeds an amount corresponding to 80 mg of morphine per day

5. History of cancer or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer

6. History of gallstone within the past 3 years. Gallstones with subsequent cholecystectomy to resolve the issues is acceptable

7. Inflammatory bowel disease (IBD) patients who have NOT been on a stable drug treatment regimen for at least the past 4 weeks

8. Evidence of active IBD in the past 12 weeks

9. Visible blood in the stool within the last 3 months

10. Catheter sepsis experienced within the last 3 months

11. Decompensated heart failure (New York Heart Association [NYHA] class III-IV) and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the last 6 months prior to screening

12. Radiation enteritis, scleroderma or other condition of intestinal dysmotility, coeliac disease, refractory or tropical sprue

13. History of alcohol and/or drug abuse within the last 12 months

14. Inadequate hepatic function as defined by: bilirubin >upper limit of normal (ULN), alanine transaminase (ALT) or aspartate transaminase (AST) >2.0 × ULN; alkaline phosphatase (ALP) >2.5 × ULN; or international normalised ratio (INR) >1.5 × ULN

15. Inadequate renal function as defined by serum creatinine or blood urea nitrogen >2.5 × ULN

16. Unplanned hospitalisation of >24 hours duration within 1 month before the screening visit

17. Systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab or other biologic therapy/immune modifiers within 30 days of screening

18. Any use of growth hormone, glutamine or growth factors such as native glucagon-like peptide 2 (GLP 2) or GLP 2 analogue within the last 3 months

19. Any use of antibiotics within the last 30 days

20. Participation in another clinical trial within the last 3 months and during this trial

21. Previously been randomised in this trial

22. Loss of blood or donation of blood or plasma >500 mL within 3 months prior to screening

23. Patient not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements

24. For any other reason judged not eligible by the investigator