A clinical trial to evaluate the effects of apraglutide on intestinal absorption.
- Conditions
- short bowel syndrome, intestinal failure (SBS-IF), colon-in-continuity (CIC)MedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2020-005129-99-FR
- Lead Sponsor
- VectivBio AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 10
1. Signed informed consent for this trial prior to any trial specific assessment
2. Male and female subjects with SBS-IF and CIC (at least 28% [Cummings, 1973] and no colostomy), receiving PS, secondary to surgical resection of the small intestine with <200 cm from duodeno-jejunal flexure, based on available medical/surgical records and with the latest intestinal resection being at least 12 months prior to Screening
3. Subject considered stable with regards to PS and weight. Stability is defined as a subject meeting all the following criteria in the 3 months preceding screening:
a) Weight change = 5%
b) PS volume change not exceeding 10-25%
c) PS energy content change not exceeding 10-25%
d) Actual PS usage in terms of volume and content matches prescribed PS (±10%)
4. Average fecal wet weight excretion of =500 g/day during the baseline metabolic balance study
5. Urine volume is =0.8 L and =2.5 L per day during baseline metabolic balance study
6. Parenteral support requirement of at least 2 days perweek as assessed at Screening
7. Willingness to remain in clinic for metabolic study on three occasions for 5 days, adhere to an individual pre-defined drinking menu and urine measurements during the 48-hour fluid balance periods
8. No restorative surgery intended to change PS requirements planned during the trial period
9. Age =18 years at screening
10. Women of childbearing potential must agree to practice effective contraception and to use a highly effective method of contraception during the trial and for 4 weeks after the End of Trial (EOT) visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner. To be considered sterilized or infertile, females must have undergone surgical sterilization (bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be post-menopausal (defined as at least 12 months amenorrhea may be confirmed with follicle-stimulating hormone test if there is doubt). Women who do not engage in heterosexual intercourse, during the trial and 4 weeks after the EoT Visit, will be allowed to join the trial without contraception following a thorough discussion with the Investigator to determine if this is feasible for the subject. The following methods are not considered acceptable methods of contraception: calendar, ovulation, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), spermicides only, and lactational amenorrhea method (LAM)
11. Male subjects with a female partner of childbearing potential must commit to practice highly effective methods of contraception (e.g., condom, vasectomy, etc.) and abstain from sperm donation during the trial and for 2 weeks after the EOT Visit. Their partners, if they are women of childbearing potential, must agree to practice effective contraception and to use a highly effective method of contraception during the trial and for 4 weeks after the EOT visit. Such methods include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implan
1. Pregnancy or lactation
2. Body mass index equal or higher than 30 kg/m2 at Screening
3. Major abdominal surgery (more than 10% intestinal resection or surgery that changes anatomy group) in the last 6 months prior to screening. Surgery for feeding tube placement allowed
4. A history of clinically significant intestinal adhesions which have not been treated surgically, increasing the risk of GI obstruction
5. Severe constipation which is not managed by dietary recommendations or laxatives
6. Enterocutaneous fistula
7. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within =5 years, except for adequately treated basal cell skin cancer
8. History of cholecystitis or biliary obstruction, unless cholecystectomy was performed prior to screening and resolved the issues
9. Evidence of active IBD in the previous 6 months prior to Screening
10. Central venous catheter sepsis experienced within the previous 8 weeks, prior to screening or use of systemic antibiotics within the last 30 days, prior to screening, due to catheter infection
11. Decompensated heart failure (New York Heart Association class III–IV) [NYHA] and/or known coronary heart disease defined as unstable angina pectoris and/or myocardial infarction within the previous 6 months prior to Screening
12. Radiation enteritis, scleroderma or other condition of severe intestinal dysmotility unrelated to SBS, coeliac disease, refractory or tropical sprue
13. History of alcohol and/or drug abuse within the previous 12 months prior to Screening
14. Child-Pugh score Class C
15. Inadequate renal function as defined by estimated glomerular filtration rate (eGFR) using the Chronic Kidney Disease Epidemiology (CKD-EPI) formula at screening visit <30 mL/min/1.73m2
16. Unplanned hospitalization of >24 hours duration within 30 days prior to Screening
17. More than two changes in systemic corticosteroids, methotrexate, cyclosporine, tacrolimus, sirolimus, infliximab, or other biologic therapy/immunomodulators within 30 days of Screening
18. Use of glutamine, or growth factors such as growth hormone (GH), somatostatin analogs, native GLP-1, GLP-2, or GLP-1 or GLP-2 analogs in the previous 6ºmonths prior to Screening
19. Known or suspected hypersensitivity to GLP-1 or GLP-2 analogs or apraglutide excipients
20. Known neutralizing antibodies (nAb) against GLP-1 or GLP-2 analogs
21. Participation in another clinical trial within 12 weeks prior to Screening and during this trial (studies with catheter locks, COVID-19 vaccines and observational trials, which are not a burden on the subject and do not interfere with the participation in this trial, are allowed)
22. Donation of blood or plasma >500 mL within 12ºweeks prior to Screening
23. Positive results for human immunodeficiency virus, hepatitis A, B and/or C tests*
24. Subject not capable of understanding or not willing to adhere to the trial visit schedules and other protocol requirements
25. Judged not eligible by the Investigator for any other reason
*Subjects recovered from hepatitis A, B or C can be enrolled; i.e., they have markers of the infection, but the viral load for hepatitis B and/or C is equal to zero. Subjects with evidence of an acute or chronically active hepatitis B or C infection should be excluded. Subjects experiencing acute hepatitis A are excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method