Efficacy and Safety of apraglutide in short bowel syndrome and intestinal failure

Phase 1

• Conditions: short bowel syndrome and intestinal failure; MedDRA version: 20.1Level: PTClassification code 10049416Term: Short-bowel syndromeSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2020-001202-32-BE
• Lead Sponsor: VectivBio AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-08
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 164

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

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 disease (IBD) or underlying condition that requires new struc 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified