Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support (NCT03415594) | Clinical Trial Compass
CompletedPhase 1/2
Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support
Denmark8 participantsStarted 2018-05-08
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Males and females with SBS secondary to surgical resection of small intestine
✓. 18-80 years of age
✓. Body Mass Index (BMI) between 16.0 and 32.0
✓. 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
✓. Parenteral support ≥3 times/week for ≥12 months according to the patient's medical record
✓. At least 6 months since last surgical bowel resection
✓. 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)
✓. 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
✕. Pregnancy or lactation
✕. Positive results on the human immunodeficiency virus (HIV), hepatitis B and/or C tests