Trial to Evaluate Efficacy and Safety of Apraglutide in SBS-IF

ID#: NCT04627025

Age: 18 years - 66+

Gender: All

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: January 26, 2021

End Date: June 30, 2023

Contact Information:
Fritze
+41615513030
Summary:

The primary objective of the trial is the confirmation of the efficacy of apraglutide to evaluate the efficacy of weekly subcutaneous apraglutide in reducing parenteral support dependency.

Eligibility:

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 work and be considered stable.

4. No restorative surgery intended to change PS requirements in the trial period.

5. Age ≥18 years at screening.

Exclusion Criteria:

1. Pregnancy or lactation.

2. Major abdominal surgery in the last 6 months prior to screening.

3. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.

4. Evidence of active inflammatory GI conditions in the previous 6 months.

5. Evidence of decompensated heart failure.

6. Evidence of severe renal or hepatic impairment.

7. Any previous use of growth factors such as growth hormone (GH), native GLP-2, GLP-1, or GLP-2 or GLP-1 analogues should be discussed with the Investigator.