short bowel syndrome and intestinal failure MedDRA version: 20.1 Level: PT Classification code 10049416 Term: Short-bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Sponsors
VectivBio AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent for this trial prior to any trial specific assessment. 2. Male and female subjects with SBS-IF, receiving parenteral support (PS), secondary to surgical resection of the small intestine with either stoma or colon-in-continuity (CIC). 3. Subject must require PS at least 3 days per week and be considered stable. 4. No planned restorative surgery or major intestinal surgery (more than 10% intestinal resection or surgery that changes anatomy group i.e. stoma or CIC), in the trial period. 5. Age =18 years at Screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 112 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 52
Exclusion criteria
Exclusion criteria: 1.Pregnancy and/or lactation. 2.Major abdominal surgery in the last 6 months prior to screening visit. 3.History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within =5 years, except for adequately treated basal cell skin cancer. 4.Active inflammatory bowel diseases (IBD) or underlying condition that requires new drug treatment or regimen changes in the previous 3 months. 5.Evidence of decompensated heart failure. 6.Evidence of severe renal or hepatic impairment. 7.Any treatment of greater than 2 weeks of growth factors such as growth hormone (GH), native GLP-2, GLP-1, short acting GLP-2 analogues (e.g., teduglutide) or GLP-1 analogues in the previous 3 months before randomization or treatment with longer acting experimental GLP-2 analogues should be discussed with the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of weekly SC apraglutide in reducing parenteral support dependency;Secondary Objective: To evaluate selected parameters indicative of clinical efficacy • To evaluate the safety and tolerability of apraglutide compared with placebo • To assess the PK of apraglutide;Primary end point(s): Relative change from baseline in actual weekly PS volume at Week 24.;Timepoint(s) of evaluation of this end point: week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Subjects who achieve a reduction of at least 1 day per week of PS from baseline at Weeks 24 / 48. •Relative change from baseline in actual weekly PS volume at Weeks 12 / 24 / 48. •SBS-IF patients reaching enteral autonomy at Weeks 24 / 48. •At least 20% reduction of PS volume from baseline at Weeks 20 / 24. •Calorie reduction from baseline in the PN at Weeks 24. •Change from baseline on QoL measures at Weeks 24 / 48. •Apraglutide PK parameters (baseline through Week 48). ;Timepoint(s) of evaluation of this end point: specified at point E.5.2 | — |
Countries
Argentina, Belgium, Czechia, Czech Republic, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Norway, Poland, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
VectivBio AG
Outcome results
None listed