CompletedPhase 3

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

United States164 participantsStarted 2021-01-26

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed informed consent for this trial prior to any trial specific assessment.
✓. 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).
✓. Subject must require PS at least 3 days per work and be considered stable.
✓. No restorative surgery intended to change PS requirements in the trial period.
✓. Age ≥18 years at screening.

Exclusion criteria

✕. Pregnancy or lactation.
✕. Major abdominal surgery in the last 6 months prior to screening.
✕. History of cancer (including colon carcinoma) or clinically significant lymphoproliferative disease within ≤5 years, except for adequately treated basal cell skin cancer.
✕. Evidence of active inflammatory GI conditions in the previous 6 months.
✕. Evidence of decompensated heart failure.
✕. Evidence of severe renal or hepatic impairment.
✕. 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.

What they're measuring

Relative change from baseline in actual weekly PS volume at Week 24.

Timeframe: At week 24 of treatment

Trial details

NCT IDNCT04627025

SponsorVectivBio AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-01-02

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